Rule2021-22041
General and Plastic Surgery Devices; Reclassification of Certain Surgical Staplers
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 8, 2021
Effective
October 8, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify surgical staplers for internal use (formerly regulated under the classification for "manual surgical instrument for general use" and assigned the product code GAG) from class I (general controls) into class II (special controls) and subject to premarket review. FDA is identifying the special controls for surgical staplers for internal use that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the device. FDA is issuing this reclassification on its own initiative based on new information. As part of this reclassification, FDA is also amending the existing classification for "manual surgical instrument for general use" to remove staplers and to create a separate classification regulation for surgical staplers that distinguishes between surgical staplers for internal use and external use.
Full Text
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[Federal Register Volume 86, Number 193 (Friday, October 8, 2021)]
[Rules and Regulations]
[Pages 56195-56204]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-22041]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA-2019-N-1250]
General and Plastic Surgery Devices; Reclassification of Certain
Surgical Staplers
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
issuing a final order to reclassify surgical staplers for internal use
(formerly regulated under the classification for ``manual surgical
instrument for general use'' and assigned the product code GAG) from
class I (general controls) into class II (special controls) and subject
to premarket review. FDA is identifying the special controls for
surgical staplers for internal use that the Agency believes are
necessary to provide a reasonable assurance of the safety and
effectiveness of the device. FDA is issuing this reclassification on
its own initiative based on new information. As part of this
reclassification, FDA is also amending the existing classification for
``manual surgical instrument for general use'' to remove staplers and
to create a separate classification regulation for surgical staplers
that distinguishes between surgical staplers for internal use and
external use.
DATES: This order is effective October 8, 2021.
FOR FURTHER INFORMATION CONTACT: George Gibeily, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4660, Silver Spring, MD 20993, 301-796-0276,
<a href="/cdn-cgi/l/email-protection#0265676d7065672c656b60676b6e7b426466632c6a6a712c656d74"><span class="__cf_email__" data-cfemail="7e191b110c191b5019171c1b1712073e181a1f5016160d50191108">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended,
establishes a comprehensive system for the regulation of medical
devices intended for human use. Section 513 of the FD&C Act (21 U.S.C.
360c) established three categories (classes) of devices, reflecting the
regulatory controls needed to provide reasonable assurance of their
safety and effectiveness. The three categories of devices are class I
(general controls), class II (special controls), and class III
(premarket approval).
Under section 513(d)(1) of the FD&C Act, devices that were in
commercial distribution before the enactment of the 1976 amendments
(Medical Device Amendments of 1976, Pub. L. 94-295), May 28, 1976
(generally referred to as ``preamendments devices''), are classified
after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
Panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
Devices that were not in commercial distribution before May 28,
1976 (generally referred to as ``postamendments devices''), are
automatically classified by section 513(f)(1) of the FD&C Act into
class III without any FDA rulemaking process. Those devices remain in
class III and require premarket approval, unless, and until: (1) FDA
reclassifies the device into class I or II or (2) FDA issues an order
finding the device to be substantially equivalent, in accordance with
section 513(i) of the FD&C Act, to a predicate device that does not
require premarket approval. The Agency determines whether new devices
are substantially equivalent to previously marketed devices by means of
premarket notification procedures in section 510(k) of the FD&C Act and
part 807, subpart E of the regulations (21 CFR part 807).
On July 9, 2012, Congress enacted the Food and Drug Administration
Safety and Innovation Act (FDASIA) (Pub. L. 112-144). Section 608(a) of
FDASIA amended section 513(e) of the FD&C Act, changing the process for
reclassifying a device from rulemaking to an administrative order.
Section 513(e)(1)(A)(i) of the FD&C Act sets forth the process for
issuing such a final order. Specifically, prior to the issuance of an
administrative order reclassifying a device, the following must occur:
(1) Publication of a proposed reclassification order in the Federal
Register, (2) a meeting of a device classification panel described in
section 513(b) of the FD&C Act, and (3) consideration of comments to a
public docket. The proposed reclassification order must set forth the
proposed reclassification and a substantive summary of the valid
scientific evidence concerning the proposed reclassification, including
the public health benefits of the use of the device, and the nature and
incidence (if known) of the risks of the device.
Section 513(e)(1)(A)(i) provides that FDA may, by administrative
order, reclassify a device based on ``new information.'' FDA can
initiate a reclassification under section 513(e) or an interested
person may petition FDA. The term ``new information,'' as used in
section 513(e) of the FD&C Act, includes information developed as a
result of a reevaluation of the data before the Agency when the device
was originally classified, as well as information not presented, not
available, or not developed at that time (See, e.g., Holland-Rantos v.
U.S. Dep't of Health, Educ. & Welfare, 587 F.2d 1173, 1174 n.1 (D.C.
Cir. 1978); Upjohn Co. v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v.
Goddard, 366 F.2d 177 (7th Cir. 1966)).
Reevaluation of the data previously before the Agency is an
appropriate basis for subsequent regulatory action where the
reevaluation is made in light of newly available regulatory authority
(see Bell, 366 F.2d at 181) or in light of changes in ``medical
science'' (see Upjohn, 422 F.2d at 951). Whether data before the Agency
are old or new, the ``new information'' to support reclassification
under section 513(e) of the FD&C Act must be ``valid scientific
evidence,'' as defined in section 513(a)(3) of the FD&C Act and 21 CFR
860.7(c)(2) (See, e.g., Gen. Med. Co. v. FDA, 770 F.2d 214 (D.C. Cir.
1985); Contact Lens Mfrs. Ass'n v. FDA, 766 F.2d 592 (D.C. Cir. 1985),
cert. denied, 474 U.S. 1062 (1986)).
FDA relies upon ``valid scientific evidence'' in the classification
process to determine the level of regulation for devices. To be
considered in the reclassification process, the ``valid scientific
evidence'' upon which the Agency relies must be publicly available.
Publicly available information
[[Page 56196]]
excludes trade secret and/or confidential commercial information, e.g.,
the contents of a pending premarket approval application (see section
520(c) of the FD&C Act).
Section 510(m) of the FD&C Act provides that a class II device may
be exempted from the premarket notification requirements under section
510(k) of the FD&C Act if the Agency determines that premarket
notification is not necessary to assure the safety and effectiveness of
the device. FDA has determined that premarket notification is necessary
to reasonably assure the safety and effectiveness of surgical staplers
for internal use. Therefore, the Agency has not exempted this class II
device from premarket notification (510(k)) submission as provided
under section 510(m) of the FD&C Act.
On April 24, 2019 (84 FR 17116), FDA published a proposed order in
the Federal Register to reclassify surgical staplers for internal use
(the proposed order). FDA also proposed special controls and proposed
amending the existing classification for ``manual surgical instrument
for general use'' to remove staplers and to create a separate
classification regulation for surgical staplers that distinguishes
between surgical staplers for internal use and external use. The period
for public comment on the proposed order closed on June 24, 2019. FDA
received and has considered comments on the proposed order, as
discussed in section III. FDA also held a meeting of the General and
Plastic Surgery Devices Advisory Panel (the Panel) on May 30-31, 2019,
in accordance with section 513(b) of the FD&C Act (21 U.S.C. 360c(b))
(Ref. 1). In publishing the proposed order, holding the Panel meeting,
and considering comments to the docket, FDA has met the requirements
for reclassification under section 513(e)(1)(A)(i) of the FD&C Act.
II. Panel Meeting
A. Panel Feedback
On May 30, 2019, the Panel met to discuss and make recommendations
regarding the reclassification of surgical staplers for internal use
from class I (general controls) to class II (special controls) (Ref.
1). At the Panel meeting, FDA presented the risks, mitigations, and
special controls identified in the proposed order.
The Panel generally agreed that the list of risks and proposed
mitigations proposed by FDA was accurate and agreed with FDA that the
risk profile was consistent with class II devices. Some Panel members
noted that adverse tissue reaction may not be a particular risk due to
the minimal patient contact duration with body tissues. Some Panel
members also stated that ``increased risk of cancer recurrence'' should
be removed from the list of risks, and no Panel members disagreed with
that position.
The Panel generally agreed that FDA's proposed special controls are
reasonable and sufficient to support reclassification of surgical
staplers for internal use to class II. Some members noted that
biocompatibility testing may not be needed as a special control due to
the limited contact duration with tissues.
The Panel also believed that usability testing should be required,
but recommended revision of the term ``labeling comprehension study''
in the special controls, since the Panel felt that the study should
focus on evaluation of the labeling rather than on the user. Some Panel
members felt that certain warnings in the labeling special controls,
such as ``establishing and maintaining proximal control of blood
vessels prior to stapling'' and ``avoidance of use of the stapler on
large blood vessels,'' should be removed, as they believed the labeling
should allow the surgeon to exercise their own clinical judgement
rather than dictating surgical practice. One Panel member additionally
implied that the term ``large blood vessels'' is vague.
Some Panel members believed that a registry could be helpful as
part of the special controls, but there was a divergence of opinion on
the need for a registry as part of device reclassification and the
ultimate utility of the data that would likely be collected.
The Panel also discussed unique sterility considerations regarding
powered staplers. The Panel also discussed additional special controls
that they believed were necessary for powered surgical staplers such as
electrical safety and electromagnetic compatibility testing and
software verification and validation. The Panel expressed the view that
powered staplers should meet these requirements.
Based upon the available scientific evidence and risks to health
posed by surgical staplers for internal use, the Panel unanimously
recommended the reclassification of surgical staplers for internal use
from class I (general controls) to class II (special controls),
agreeing with FDA's conclusion that general controls by themselves were
insufficient to provide reasonable assurance of safety and
effectiveness.
B. FDA Response to Panel Feedback and Changes in the Final Order
The Panel agreed with FDA in recommending the reclassification of
surgical staplers for internal use from class I (general controls) to
class II (special controls). The Panel generally agreed with the risks
to health identified by FDA and the applicable special controls
associated with the identified risks. FDA's responses to the
recommendations are detailed in this section. As discussed in detail in
sections III and IV below, FDA also considered comments from industry,
professional societies, and stakeholders in developing the special
controls in this final order. However, here in section II, we
specifically address the Panel recommendations and FDA's response.
1. Risks
The Panel recommended removing increased risk of cancer recurrence
and adverse tissue reaction from the risks to health presented at the
Panel meeting. While surgical stapler malfunctions have resulted in
complications such as anastomotic leaks, which have been associated
with an increased risk of cancer recurrence, FDA agrees that there is
limited evidence directly linking surgical stapler failure or
malfunction with an increased risk of cancer recurrence (Refs. 2- 4).
Therefore, due to the limited evidence directly linking surgical
stapler failure or malfunction with an increased risk of cancer
recurrence, FDA agrees with removing increased risk of cancer
recurrence from the list of complications associated with device
failure/malfunction. FDA does not agree that adverse tissue reaction
should be removed as a risk to health, as staplers for internal use
contain patient-contacting materials that contact internal tissues, and
these patient-contacting device materials may pose a risk of adverse
tissue reaction if not adequately demonstrated to be biocompatible. The
demonstration of biocompatibility for these devices is consistent with
our approach for other devices with similar type and duration of
contact; therefore, FDA has not removed the applicable special control
regarding biocompatibility (Ref. 5).
The Panel had specifically been asked to consider additional risks
posed by powered staplers that were not identified in the proposed
order. The Panel noted that the risks associated with sterility are
different for non-powered staplers, which are generally packaged
sterile, and powered staplers, part of which must be reprocessed.
[[Page 56197]]
2. Special Controls
The Panel discussed and provided recommendations regarding the
biocompatibility, labeling comprehension study, labeling, and sterility
special controls identified in the proposed order. The Panel also
discussed the possible addition of special controls regarding use of
registries and powered staplers.
As discussed above in section II.B.1., FDA has not removed the
special control regarding biocompatibility since surgical staplers for
internal use contain patient-contacting device materials that may pose
a risk of adverse tissue reaction if not adequately demonstrated to be
biocompatible.
FDA acknowledges and agrees with the Panel's recommendation that
``labeling comprehension'' testing should focus on evaluation of the
clarity of the labeling rather than on the user's comprehension of the
labeling. In response to the Panel's recommendation to revise the term
``labeling comprehension study'' in the special controls, FDA notes
that the term ``labeling comprehension study'' is commonly used when
referring to a study assessing the extent to which the labeling conveys
the intended message to the user, such that the user can understand and
apply this information when making decisions regarding device selection
and use. However, a labeling comprehension study may not be the only
way to assess how well the labeling results in use of the device as
intended, therefore we are revising this special control to use the
term ``human factors testing'' in place of ``usability testing and
labeling comprehension study.'' FDA continues to find that such human
factors testing is necessary to mitigate the risk of complications
associated with use error or improper device selection and use
specifically related to device labeling.
Based, in part, on feedback from the Panel that the labeling should
allow surgeons to exercise their own clinical judgement, FDA has made
several edits to the labeling special controls. FDA has revised the
warning regarding ``establishing and maintaining proximal control of
blood vessels'' to state ``establishing proximal control of blood
vessels prior to stapling where practical'' and to also include
``methods of blood vessel control in the event of stapler failure.''
FDA has revised the warning regarding ``avoidance of use of the stapler
on large blood vessels, such as the aorta'' to state ``avoidance of use
of the stapler on the aorta.'' FDA has also removed the requirement to
include specific user instructions for evaluation of the resultant
staple line from the labeling special controls.
While the Panel had a distinct discussion on the possible addition
of registries as a special control, use of registries was not added as
a special control due in part to the divergence of the Panel's opinion
on the necessity for a registry as part of device reclassification.
While FDA acknowledges that use of registries may be helpful in
understanding the performance of these devices, FDA determines that
mandating the use of registries is not needed to provide a reasonable
assurance of the safety and effectiveness of surgical staplers for
internal use.
Finally, the Panel did not disagree with FDA's request to consider
the inclusion of specific special controls for powered surgical
staplers for internal use. Special controls regarding electrical
safety, electromagnetic compatibility, software verification,
validation, and hazard analysis for powered staplers have been added
accordingly. While FDA acknowledges that powered staplers may have
unique sterility considerations as discussed by the Panel, FDA notes
that all surgical staplers, both manual and powered, must be
demonstrated to be sterile. Therefore, the special control regarding
sterility (``Performance data must demonstrate the sterility of the
device'') remains unchanged.
III. Comments on the Proposed Order and FDA Response to Comments
A. Introduction
In response to the April 24, 2019, proposed order (84 FR 17116),
FDA received seven sets of comments to the docket for the proposed
order (FDA-2019-N-1250), some of which contain one or more comments on
more than one issue. In addition, FDA received two sets of public
comments to the docket for FDA's draft guidance, ``Surgical Staplers
and Staples for Internal Use--Labeling Recommendations'' (FDA-2019-D-
1262) that contained one or more comments regarding the proposed order.
Collectively, these comments originated from individual consumers,
academia, healthcare professionals, healthcare associations, and
industry. All commenters support the proposed reclassification of
surgical staplers for internal use, and a few expressed concerns
regarding specific special controls, which we address in section B.
below.
Additionally, FDA received some comments to the docket for the
proposed order that are regarding FDA's ``Draft Surgical Staplers and
Staples for Internal Use--Labeling Recommendations'' guidance.
Elsewhere in this issue of the Federal Register, FDA is publishing a
notice of availability for the final ``Surgical Staplers and Staples
for Internal Use--Labeling Recommendations'' guidance. These comments
were considered in the finalization of this guidance. As discussed
below, FDA intends for the ``Surgical Staplers and Staples for Internal
Use--Labeling Recommendations'' guidance to provide recommendations to
help manufacturers comply with the labeling special controls. As such,
FDA has utilized the ``Surgical Staplers and Staples for Internal Use--
Labeling Recommendations'' guidance to provide additional
clarification, where appropriate.
The order of response to the commenters is purely for
organizational purposes and does not signify the comment's value or
importance nor the order in which comments were received. Certain
comments are grouped together under a single number because the subject
matter is similar.
B. Description of Comments and FDA Response
(Comment 1) Some commenters shared their own personal experiences
with surgical staplers for internal use, such as adverse events
experienced during surgeries, types of malfunctions encountered with
surgical staplers, or best practices taken to help ensure safety of
surgical staplers. One of these commenters encouraged FDA to put into
effect whatever additional safety measures it sees fit to make surgical
staplers for internal use safer.
(Response 1) FDA notes that, as discussed in the proposed order,
malfunctions and misuse associated with surgical staplers for internal
use have resulted in serious adverse events, including deaths. FDA
determines that reclassifying surgical staplers for internal use from
class I to class II, establishing special controls, and requiring
premarket review will help ensure a reasonable assurance of safety and
effectiveness for these devices.
(Comment 2) One commenter requested that FDA consider establishing
requirements to make public announcements about large scale problems
with medical devices.
(Response 2) Requiring public announcements about large scale
problems with medical devices falls outside the scope of FDA's
reclassification of surgical staplers for internal use described in
this final order. Nonetheless, FDA routinely posts
[[Page 56198]]
Medical Device Safety Communications to describe FDA's analysis of a
current issue or problem and provide specific regulatory approaches and
clinical recommendations for patient management. FDA's publicly
available Medical Device Reporting Database includes information on
devices that may have malfunctioned or caused a death or serious
injury. Likewise, FDA's publicly available Medical Device Recalls
database provides information on medical device recalls. In addition,
FDA posts consumer information about Class I and some Class II and III
recalls on its website in order to ensure that patients are aware of
the seriousness of the potential health hazard posed by exposure to the
product.
(Comment 3) Some commenters discussed the benefits of surgical
staplers for internal use, such as decreasing operative time, reducing
surgical variability, and enabling more complex surgical procedures.
Some commenters stated that the risks of the device need to be
considered against these benefits, and that the number of adverse
events need to be considered in the context of the large number of
surgical procedures performed using these devices.
(Response 3) FDA agrees that surgical staplers for internal use
offer many important benefits, and that the risks of these devices need
to be considered against their benefits. As described in the proposed
order, FDA set forth the proposed reclassification and a substantive
summary of the valid scientific evidence, including the public health
benefits of the use of the device, and the nature and incidence of the
risks of the device. Based on our analysis of the benefits and risks
posed by surgical staplers for internal use, FDA determines that
general controls on their own are insufficient to provide reasonable
assurance of safety and effectiveness. The special controls identified
in this final order, together with general controls, are necessary to
provide a reasonable assurance of safety and effectiveness for surgical
staplers for internal use, and as such, class II is the more
appropriate classification for these devices.
(Comment 4) Similar to the Panel's feedback, some commenters felt
that increased risk of cancer recurrence should be removed from the
list of risks to health due to lack of evidence associating surgical
staplers for internal use with an increased risk of cancer recurrence.
(Response 4) As discussed above, in section II. B., while surgical
stapler malfunctions have resulted in complications such as anastomotic
leaks, and anastomotic leaks have been associated with an increased
risk of cancer recurrence, FDA agrees that there is limited evidence
directly linking surgical stapler failure/malfunction with an increased
risk of cancer recurrence (Refs. 2-4). Therefore, FDA agrees with
removing increased risk of cancer recurrence from the list of
complications associated with device failure/malfunction in the risks
to health.
(Comment 5) Similar to the Panel's feedback, some commenters felt
that adverse tissue reaction should be removed as a risk to health
associated with surgical staplers for internal use, as the stapler only
has incidental contact with the patient.
(Response 5) As discussed above, in section II.B., FDA does not
agree that adverse tissue reaction should be removed as a risk to
health, as staplers for internal use contain patient-contacting
materials that contact internal tissues, and these patient-contacting
device materials may pose a risk of adverse tissue reaction if not
adequately demonstrated to be biocompatible. The demonstration of
biocompatibility for these devices is consistent with our approach for
other devices with similar type and duration of contact, therefore the
associated special control has also been maintained (Ref. 5).
(Comment 6) Some commenters requested that FDA work collaboratively
with industry and professional societies to develop the special
controls (e.g., specific language for warnings) and to develop a
uniform color coding system for all stapler reloads.
(Response 6) FDA has considered extensive comments from industry,
professional societies, and other stakeholders in developing the
special controls in this final order. While color coding is helpful and
FDA would support development of a uniform color coding system if it
came from a consensus body, FDA believes that the special controls in
this final order, together with general controls, are sufficient to
provide a reasonable assurance of safety and effectiveness for surgical
staplers for internal use.
(Comment 7) One commenter stated that the special controls for
surgical staplers for internal use should be established in accordance
with least burdensome principles.
(Response 7) As stated in FDA's guidance, ``The Least Burdensome
Provisions: Concepts and Principles,'' FDA defines ``least burdensome''
to be the minimum amount of information necessary to adequately address
a relevant regulatory question or issue through the most efficient
manner at the right time (Ref. 6). FDA used the least burdensome
approach in weighing the risks of surgical staplers for internal use
with their benefits. FDA finds that the special controls identified in
this final order represent the minimum amount of information necessary
to provide a reasonable assurance of the safety and effectiveness of
these devices.
(Comment 8) One commenter felt that the proposed performance
testing special controls represented a reasonable approach for
evaluating the safety and effectiveness of surgical staplers for
internal use, but that greater specifics regarding the standards,
methods, and relevance of the proposed testing controls are needed to
fully evaluate the proposed special controls.
(Response 8) FDA agrees that the performance testing special
controls identified in this final order are necessary to provide a
reasonable assurance of the safety and effectiveness for these devices.
FDA notes that the performance testing special controls are stated
broadly to allow flexibility in different approaches in complying with
the special controls.
(Comment 9) Some commenters noted that firing force is an important
parameter for manual surgical staplers for internal use, but is not
applicable to powered surgical stapler devices.
(Response 9) FDA agrees that firing force is an important parameter
applicable to manual surgical staplers for internal use and is not
applicable to powered surgical staplers. Therefore, FDA has revised the
performance testing special controls to include measurement of the
worst-case deployment pressures on stapler firing force specifically
for manual staplers.
(Comment 10) Similar to the Panel's feedback, some commenters noted
the importance of ensuring that the product labeling and instructions
for use do not interfere with clinical decision making and a
physician's ability to exercise his or her professional judgement. The
commenters noted that too much information in the product labeling can
make the labeling difficult to read, reducing its value to physicians,
and provided a general recommendation to make the labeling special
controls less prescriptive.
(Response 10) As discussed above, in section II, regarding the
Panel's discussion of the proposed special control for a labeling
comprehension study, FDA acknowledges the concern that too much
information in the product labeling can make the labeling difficult to
read, and that it is important for the labeling to be clear for the
user. However, FDA also notes that, as
[[Page 56199]]
discussed in the proposed order, there have been a large number of
adverse events associated with use of both surgical staplers and
staples for internal use; both device misuse and device malfunctions
are root causes of these adverse events. Therefore, FDA finds it is
essential to communicate specific information about the risks,
limitations, and directions for use in the labeling for surgical
staplers and staples for internal use to lower the risk of occurrence
of these adverse events and to promote safe and effective use of these
devices.
As discussed separately in the responses to the comments below in
section IV, FDA has chosen to remove or revise certain labeling special
controls in an effort to allow for physician discretion as discussed
with the Panel, but we continue to conclude that other labeling special
controls are necessary to provide a reasonable assurance of the safety
and effectiveness of these devices.
(Comment 11) Some commenters felt that the contraindication that
the device should not be used to staple tissues that are necrotic,
friable, or have altered integrity should be removed from the stapler
labeling as it extends into the realm of surgical practice and involves
the application of medical judgement that should be left to trained
surgeons.
(Response 11) FDA disagrees that the contraindication regarding
stapling of tissues that are necrotic, friable, or have altered
integrity should be removed from the labeling. FDA notes that
application of staples to tissues that are necrotic, friable, or have
altered integrity has resulted in complications such as, but not
limited to, tissue damage, anastomotic leakage, bleeding, abscess,
sepsis, peritonitis, and hemorrhage. To FDA's knowledge, there is no
known benefit of applying surgical staples to tissues that are
necrotic, friable, or have altered integrity. Therefore, FDA determines
that the risk of stapling tissues that are necrotic, friable, or have
altered integrity outweighs any reasonably foreseeable benefit due to
known complications. FDA finds that this contraindication is necessary
to mitigate the risks of complications associated with improper device
use and to provide a reasonable assurance of the safety and
effectiveness of these devices.
(Comment 12) One commenter felt that the warning to visually
inspect for inclusion of unintended anatomic structures within the
staple line should be removed from the stapler labeling as it extends
into the realm of surgical practice and involves the application of
medical judgement that should be left to trained surgeons.
(Response 12) FDA disagrees that the warning regarding avoidance of
obstructions to the creation of the staple line and the unintended
stapling of other anatomic structures should be removed from the
labeling. As noted in the proposed order, obstructions to the creation
of the staple line and unintended stapling of anatomic structures have
been associated with known hazards. For example, FDA has received
medical device reports where obstructions to the staple line and/or
unintended stapling of anatomic structures have resulted in anastomotic
leaks and other injuries. Therefore, FDA finds that this warning is
necessary to mitigate the risks of complications associated with
improper device use and to provide a reasonable assurance of the safety
and effectiveness of these devices.
(Comment 13) Similar to the Panel discussion, some commenters felt
that the warning to establish and maintain adequate proximal control of
blood vessels prior to stapling should be removed from the stapler
labeling as it extends into the realm of surgical practice and involves
the application of medical judgement that should be left to trained
surgeons.
(Response 13) FDA disagrees that the warning to establish and
maintain adequate proximal control of blood vessels prior to stapling
should be removed entirely, as it is important to have methods of blood
vessel control in place in the event of stapler failure to prevent the
risk of uncontrolled bleeding. However, FDA acknowledges there are
situations where it may not be practical to establish proximal control
of blood vessels prior to stapling. Therefore, FDA has revised the
labeling special control to include a warning regarding the
establishment of proximal control of blood vessels prior to stapling
``where practical'' and establishment of ``methods of blood vessel
control in place in the event of stapler failure.'' FDA finds that this
warning is necessary to mitigate the risks of complications associated
with improper device use and to provide a reasonable assurance of the
safety and effectiveness of these devices.
(Comment 14) One commenter felt that the warning that clamping and
unclamping of delicate tissue structures, such as venous structures and
bile ducts, may result in damage to tissue irrespective of stapler
firing, should be removed from the stapler labeling as it extends into
the realm of surgical practice and involves the application of medical
judgement that should be left to trained surgeons.
(Response 14) FDA disagrees that the warning regarding avoidance of
clamping and unclamping of delicate tissue structures should be removed
from the labeling. As discussed in the proposed order, clamping and
unclamping of delicate tissue structures have been associated with
known hazards such as tissue damage. For example, FDA has received
medical device reports where clamping of the stapler has resulted in
tissue damage or bleeding. As also noted in FDA's Letter to Health Care
Providers, ``Safe Use of Surgical Staplers and Staples,'' clamping of
staplers on delicate tissue can cause injury even if no staples are
fired (Ref. 7). Therefore, FDA finds that this warning is necessary to
mitigate the risks of complications associated with improper device use
and to provide a reasonable assurance of the safety and effectiveness
of these devices.
(Comment 15) Some commenters felt that the warning regarding
measures to take if a stapler malfunction occurs while applying staples
across a blood vessel, including clamping or ligating the vessel before
releasing the stapler, while the stapler is still closed on the tissue,
should be removed from the stapler labeling as it extends into the
realm of surgical practice and involves the application of medical
judgement that should be left to trained surgeons.
(Response 15) FDA agrees that the warning regarding ``clamping or
ligating the vessel before releasing the stapler, while the stapler is
still closed on the tissue'' may be too prescriptive and has removed
this from the labeling special controls. Nonetheless, FDA continues to
find that it is important to have methods of blood vessel control in
place in the event of stapler failure in order to prevent the risk of
uncontrolled bleeding. Therefore, FDA has modified the remainder of the
labeling special controls to add a warning regarding methods of blood
vessel control in the event of stapler failure. FDA finds that this
warning is necessary to mitigate the risks of complications associated
with improper device use and to provide a reasonable assurance of the
safety and effectiveness of these devices.
(Comment 16) Consistent with the Panel discussion, commenters
requested revision or removal of the warning regarding ``avoidance of
use of the stapler on large blood vessels, such as the aorta.'' Some
commenters felt that the term ``large blood vessels'' is vague and
recommended revising the statement to warn specifically against
stapling the aorta. Some commenters noted that many surgical staplers
are contraindicated for use on the aorta and felt that this statement
should only be
[[Page 56200]]
included as a warning if it is not already included as a
contraindication. Other commenters felt that this statement should be
removed from the labeling, since it extends into the realm of surgical
practice and involves the application of a surgeon's medical judgement.
(Response 16) FDA agrees that use of the term ``large blood
vessels'' may be subject to interpretation and has revised the special
control to remove ``avoidance of use of the stapler on large blood
vessels'' to leave more room for surgeon judgement, which FDA believes
is appropriate here. Nonetheless, FDA has retained the warning
regarding ``avoidance of use of the stapler on the aorta.'' As
discussed at the Panel meeting, FDA has received several medical device
reports where stapling the aorta has resulted in serious adverse
events, such as significant blood loss. Based on a benefit risk
analysis, as well as information received from medical device reports,
FDA finds that the risk of stapling the aorta outweighs the risk of
stapling other large blood vessels. Therefore, FDA finds that a warning
regarding avoidance of use of the stapler on the aorta is necessary to
mitigate risks of complications associated with improper device use and
to ensure a reasonable assurance of safety and effectiveness of these
devices.
(Comment 17) One commenter noted that premarket testing for staple
line integrity provides important information for assessing the safety
and effectiveness of surgical staplers. Nonetheless, some commenters
felt that the procedures for evaluating staple line integrity should
not be included in the directions for use, as these procedures extend
into the realm of surgical practice and may differ depending on
different circumstances (e.g., patient conditions, tissue types,
surgeon's training and experience).
(Response 17) FDA agrees that premarket testing for staple line
integrity provides important information for assessing the safety and
effectiveness of surgical staplers for internal use. Therefore,
confirmation of staple line integrity remains as a performance testing
special control. FDA acknowledges that procedures for evaluating staple
line integrity may differ depending on different circumstances.
Therefore, FDA has removed the requirement to include specific user
instructions for evaluation of the resultant staple line from the
labeling special controls.
(Comment 18) One commenter felt that the warning to ensure stapler
compatibility with staples is unnecessary, since the labeling of the
device must include a list of staples with which the stapler has been
demonstrated to be compatible.
(Response 18) Even with a list of compatible staples present in the
labeling, it is possible that a user may still try to use the stapler
with an incompatible staple if a warning to ensure stapler
compatibility with staples is not present. Therefore, consistent with
the proposed order, FDA continues to find that the warning to ensure
stapler compatibility with staples is necessary to mitigate the risk of
complications associated with improper device use and to ensure a
reasonable assurance of safety and effectiveness of these devices.
(Comment 19) One commenter felt that the warning to ensure
avoidance of obstructions to the creation of the staple line should not
be included in the labeling, since clinical circumstances exist in
which it may be necessary or appropriate to staple across an
obstruction, e.g., a prior staple line.
(Response 19) As noted in response 12 above, stapling across
obstructions have been associated with risks such as anastomotic leaks
and other injuries. While FDA acknowledges there may be clinical
circumstances when a surgeon may deem it necessary or appropriate to
cross staple lines, FDA notes that additional types of obstructions
beyond prior staple lines exist (e.g., clips, ligatures, drainage
tubes), and that such obstructions should be avoided due to the
associated risks. Therefore, FDA finds that the warning to ensure
avoidance of obstructions to the creation of the staple line should be
included in the labeling to mitigate the risk of complications
associated with improper device use and to ensure a reasonable
assurance of safety and effectiveness of these devices. As noted below,
FDA has additionally revised the special controls to include a labeling
requirement for a warning regarding risks of crossing staple lines in
response to a comment recommending the addition of such a warning in
the docket for FDA's draft guidance, ``Surgical Staplers and Staples
for Internal Use--Labeling Recommendations'' (FDA-2019-D-1262).
(Comment 20) One commenter noted that premarket testing for staple
line strength provides important information for assessing the safety
and effectiveness of surgical staplers. Nonetheless, some commenters
noted that there are no standardized test methods for evaluating staple
line strength (e.g., burst strength). These commenters felt that staple
line strength (e.g., burst strength) should not be included in the
device labeling until standardized testing methodology is developed.
(Response 20) FDA agrees that premarket testing for staple line
strength provides important information for assessing the safety and
effectiveness of surgical staplers for internal use. Therefore,
measurement of staple line strength remains as a performance testing
special control.
For the reasons discussed in the proposed order, FDA finds that the
labeling must include identification of key performance parameters and
technical characteristics of the stapler and compatible staples needed
for safe use of the device. The commenters' recommendations regarding
removing staple line strength from product labeling due to lack of
standardized methodology were considered in the finalization of FDA's
``Surgical Staplers and Staples for Internal Use--Labeling
Recommendations'' guidance, which provides FDA's recommendations
regarding key performance parameters and technical characteristics that
should be included in the labeling for surgical staplers. At this time,
due to the lack of standardized testing methodology for evaluating
staple line strength, FDA revised the final guidance to remove staple
line strength from the list of recommendations for labeling of key
technical characteristics and performance parameters.
(Comment 21) One commenter noted that premarket testing for staple
formation provides important information for assessing the safety and
effectiveness of surgical staplers. Nonetheless, some commenters noted
that there are no standardized test methods for evaluating the
percentage of properly formed staples at the maximum and minimum tissue
thickness. These commenters felt that percentage of properly formed
staples at the maximum and minimum tissue thickness should not be
included in the device labeling until standardized testing methodology
is developed.
(Response 21) FDA agrees that premarket testing for staple
formation provides important information for assessing the safety and
effectiveness of surgical staplers for internal use. Therefore,
evaluation of staple formation characteristics in the maximum and
minimum tissue thicknesses for each staple type remains as a
performance testing special control.
In addition, FDA finds that the labeling must include
identification of key performance parameters and technical
characteristics of the stapler and compatible staples needed for safe
use of the device. FDA's ``Surgical Staplers and Staples for Internal
Use--
[[Page 56201]]
Labeling Recommendations'' Guidance provides FDA's recommendations
regarding key performance parameters and technical characteristics to
include in the labeling for surgical staplers. The commenters'
recommendations regarding percentage of properly formed staples were
considered in the finalization of the guidance. Specifically,
``percentage of properly formed staples at the maximum and minimum
tissue thickness'' was removed from the list of recommended key
performance parameters and technical characteristics due to the lack of
standardized test methodology for evaluating these parameters.
(Comment 22) One commenter asked FDA to clarify what is meant by
``safety mechanisms'' for surgical staplers for internal use.
(Response 22) FDA has provided examples and clarification for what
is meant by ``safety mechanisms'' for surgical staplers for internal
use in FDA's ``Surgical Staplers and Staples for Internal Use--Labeling
Recommendations'' guidance. Specifically, the final guidance states
that safety mechanisms include ``e.g., identification of whether a
stapler has built-in methods for assessing and/or limiting operation
when the underlying tissues are outside of a predefined range.''
``Lock-out'' and ``color firing zone'' are two examples of safety
mechanisms for surgical staplers for internal use provided in the
guidance.
(Comment 23) One commenter asked FDA to revise the labeling special
control regarding inclusion of specific user instructions for
``evaluation of the appropriateness of the target tissue for stapling''
to include examples of procedures that may be used for determining that
a tissue is appropriate for stapling, and to provide clarification for
the types of target tissue. Another commenter requested that FDA remove
this special control altogether, as it extends into the realm of
surgical practice and involves the application of medical judgement
that should be left to trained surgeons.
(Response 23) FDA does not agree that this special control should
be removed, as FDA believes instructions for ``evaluation of the
appropriateness of the target tissue for stapling'' are important to
include within specific user instructions to reduce the risk of
complications associated with improper device use. FDA has not included
examples of procedures that may be used for determining that a tissue
is appropriate for stapling or examples of types of tissue, since the
examples of procedures and tissue types may vary depending on the
design and intended use the stapler. Instead, manufacturers should
identify appropriate procedures and tissue types based on the design
and intended use of their own specific stapler.
(Comment 24) Some commenters requested that FDA clarify
expectations for the evaluation of marketed surgical stapler products
that were previously cleared. Some commenters felt that the special
controls should not be retroactively applied to devices that already
have been 510(k) cleared and have an established safety profile. Other
commenters felt that FDA should evaluate previously cleared devices to
determine if the devices and information contained in the previously
cleared submissions meet the new special controls.
(Response 24) FDA finds that all surgical staplers for internal
use, including previously cleared devices and new devices, must comply
with the special controls identified in this final order to ensure a
reasonable assurance of safety and effectiveness for these devices.
Manufacturers should refer to section V (Implementation Strategy) of
this final order for information on dates when FDA intends to enforce
compliance with the final order. It is the manufacturer's
responsibility to ensure compliance with applicable laws and
regulations administered by FDA. Manufacturers should refer to FDA's
guidance, ``Deciding When to Submit a 510(k) for a Change to an
Existing Device'' (Ref. 8) to determine whether a new 510(k) is
required for changes to an existing device.
IV. Changes in the Final Order
FDA is adopting the majority of our findings under section 513(e)
of the FD&C Act, as published in the preamble to the proposed order (84
FR 17116). For the reasons described previously in sections II and III,
FDA has made revisions in this final order in response to feedback from
the Panel and comments regarding the proposed order that were submitted
to public dockets.
Based, in part, on the Panel feedback and comments to the proposed
reclassification order, FDA is issuing the following revised list of
risks and Risks to Health and Risk Mitigation Table (table 1). The list
reflects the addition of risks specific to powered staplers and the
removal of ``increased risk of cancer recurrence'' as a risk:
<bullet> Complications associated with device failure/malfunction.
Device failures or malfunctions may result in prolonged surgical
procedures, unplanned surgical interventions, and other complications
such as bleeding, sepsis, fistula formation, tearing of internal
tissues and organs, and death. Additionally, for powered staplers,
faulty hardware or software may cause electrical hazards or
electromagnetic interference with other devices, such as the risk of
interference with operating monitors, misfiring or locking of the
stapler.
<bullet> Complications associated with use error/improper device
selection and use. Use error may result from a device design that is
difficult to operate and/or labeling that is difficult to comprehend.
For example, user difficulty in firing the stapler may result in
staples not being fully deployed, and misfiring may result in staples
being inadvertently applied to the wrong tissue. Inadequate
instructions for use may result in selection of incorrectly sized
staples for the target tissue. When staples are applied to the wrong
tissue or when incorrectly sized staples are applied, staples are
unable to properly approximate the underlying tissue, resulting in
tissue damage, anastomotic leakage, and bleeding. This in turn, may
lead to more severe complications, such as abscess, sepsis,
peritonitis, hemorrhage, or death.
<bullet> Adverse tissue reaction. If the patient-contacting
materials of the device are not biocompatible, local tissue irritation
and sensitization, cytotoxicity, or systemic toxicity may occur when
the device contacts sterile tissue.
<bullet> Infection. If the device is not adequately reprocessed or
sterilized, the device may introduce pathogenic organisms into sterile
tissue and may cause an infection in a patient.
Table 1--Risks to Health and Mitigation Measures for Surgical Staplers
for Internal Use
------------------------------------------------------------------------
Identified risks to health Mitigation measures
------------------------------------------------------------------------
Complications associated with device Performance testing; Labeling;
failure/malfunction. and for powered staplers only:
Electrical, thermal, and
mechanical safety testing;
Electromagnetic compatibility
testing; Software validation,
verification, and hazard
analysis.
[[Page 56202]]
Complications associated with use error/ Human Factors testing and
improper device selection and use. Labeling.
Adverse Tissue Reaction................ Biocompatibility evaluation.
Infection.............................. Labeling, Sterility testing,
and Shelf-Life Testing.
------------------------------------------------------------------------
FDA modified the special controls to provide additional specificity
regarding manual and powered staplers, where appropriate. Specifically,
FDA modified the performance testing special controls to include
clarification that measurement of worst-case deployment pressures on
stapler firing force is applicable only to manual staplers (see Sec.
878.4740(b)(2)(i)(B)). FDA added special controls for powered staplers
regarding electrical safety, electromagnetic compatibility, software
verification, validation, and hazard analysis (see Sec.
878.4740(b)(2)(ii) and (b)(2)(iii)).
FDA also modified the special controls to refine certain labeling
requirements. Specifically, FDA modified the requirement for a warning
regarding ``establishing and maintaining proximal control of blood
vessels prior to stapling'' to ``Establishing proximal control of blood
vessels prior to stapling where practical'' (see Sec.
878.4740(b)(2)(ix)(B)(v)). FDA replaced the requirement for a warning
regarding ``appropriate measures to take if a stapler malfunction
occurs while applying staples across a blood vessel, such as clamping
or ligating the vessel before releasing the stapler, while the stapler
is still closed on the tissue'' with the requirement for a warning
regarding ``methods of blood vessel control in the event of stapler
failure.'' (see Sec. 878.4740(b)(2)(ix)(B)(v)). These edits were made
for the reasons described above, including feedback from the Panel and
commenters regarding instances where labeling should provide
flexibility for a physician to exercise his or her professional
judgement. FDA modified the requirement for a warning regarding
``avoidance of use of the stapler on large blood vessels, such as the
aorta'' to a warning regarding ``avoidance of use of the stapler on the
aorta'' (see Sec. 878.4740(b)(2)(ix)(B)(iv)) in response to comments
that use of the term ``large blood vessels'' is vague. FDA has also
revised the special controls to remove the requirement for specific
user instructions associated with ``evaluation of the resultant staple
line'' (see Sec. 878.4740(b)(2)(ix)(C)) in response to comments that
procedures for evaluating staple line integrity may differ depending on
different circumstances.
Elsewhere in this issue of the Federal Register, FDA is publishing
a notice of availability for the final guidance, ``Surgical Staplers
and Staples for Internal Use--Labeling Recommendations.'' FDA made
additional revisions in this final order to reflect changes made during
finalization of the guidance based on the feedback specifically on that
document to the guidance docket. Specifically, FDA revised the special
controls to include a labeling requirement for a warning regarding the
risks of crossing staple lines (see Sec. 878.4740(b)(2)(ix)(B)(vii))
in response to a comment recommending the addition of such a warning to
the guidance. FDA notes that a risk of increased leak rates when staple
lines are crossed has been commonly reported in the medical literature
(Refs. 9 and 10). Therefore, FDA finds that this warning is necessary
to mitigate the risks of complications associated with improper device
use and to provide a reasonable assurance of the safety and
effectiveness of these devices.
In response to a comment recommending removal of the
contraindication for stapling of ``tissues outside the labeled limits
of tissue thickness'' from the guidance, FDA revised the special
controls to change this contraindication to a warning (see Sec.
878.4740(b)(2)(ix)(B)(i)). FDA has changed the contraindication
regarding stapling ``tissues outside the labeled limits for maximum and
minimum tissue thickness'' to a warning instead of a contraindication
so as not to impinge on surgeon judgement and since there is currently
no standardized mechanism to accurately measure tissue thickness
intraoperatively. Nonetheless, FDA notes that stapling of tissues
outside labeled limits has been associated with serious adverse events,
such as anastomotic leakage and bleeding, in medical device reports.
Therefore, FDA finds that a warning regarding stapling tissues outside
labeled limits is necessary to mitigate the risks of complications
associated with improper device use and to provide a reasonable
assurance of the safety and effectiveness of these devices.
FDA also modified the contraindication regarding ``stapling of
necrotic or ischemic tissues'' to ``stapling of tissues that are
necrotic, friable, or have altered integrity'' to promote consistency
with the language used in the guidance (see Sec.
878.4740(b)(2)(ix)(A)). FDA notes that ``necrotic or ischemic tissues''
are a subset of ``tissues that are necrotic, friable, or have altered
integrity.'' As explained above, FDA has determined that the risk of
stapling tissues that are necrotic, friable, or have altered integrity
outweighs any reasonably foreseeable benefit due to known
complications.
FDA is issuing this final order revising Sec. 878.4800 by removing
the classification of surgical staplers and codifying surgical staplers
in the new 21 CFR 878.4740, under which surgical staplers for internal
use is classified into class II with special controls and surgical
staplers for external use remain in class I, exempt from premarket
notification. In this final order, we have identified the special
controls under section 513(a)(1)(B) of the FD&C Act that, together with
general controls, provide a reasonable assurance of the safety and
effectiveness for surgical staplers for internal use.\1\
---------------------------------------------------------------------------
\1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------
FDA may exempt a class II device from the premarket notification
requirements, under section 510(m) of the FD&C Act, if FDA determines
that premarket notification is not necessary to provide reasonable
assurance of the safety and effectiveness of the devices. FDA has
determined that premarket notification is necessary to provide
reasonable assurance of safety and effectiveness of surgical staplers
for internal use, and therefore, this device type is not exempt from
premarket notification requirements.
The device is assigned the generic name surgical stapler for
internal use,
[[Page 56203]]
and it is identified as a specialized prescription device used to
deliver compatible staples to internal tissues during surgery for
resection, transection, and creating anastomoses.
V. Implementation Strategy
The order is effective on its date of publication in the Federal
Register.
<bullet> Surgical staplers for internal use that have not been
offered for sale prior to the effective date of the final order or have
been offered for sale but are required to submit a new 510(k) under 21
CFR 807.81(a)(3): Manufacturers would have to obtain 510(k) clearance
before marketing their devices after the effective date of the order.
If a manufacturer markets such a device without receiving 510(k)
clearance, then FDA would consider taking action against such a
manufacturer under its usual enforcement authorities and policies.
<bullet> Surgical staplers for internal use that have been offered
for sale prior to the effective date of the final order and do not
already have 510(k) clearance: FDA does not intend to enforce
compliance with the 510(k) requirement or special controls until 180
days after the effective date of the final order. After that date, if a
manufacturer continues to market such a device but does not have 510(k)
clearance or FDA determines that the device is not substantially
equivalent or not compliant with special controls, then FDA would
consider taking action against such manufacturer under its usual
enforcement authorities and policies.
For surgical staplers for internal use that have prior 510(k)
clearance, FDA would accept a new 510(k) and would issue a new
clearance letter, as appropriate, indicating substantial equivalence
and special controls compliance. These devices could serve as
predicates for new devices. These clearance letters would be made
publicly available in FDA's 510(k) database, and compliance with
special controls at the time of clearance would also be stated in the
publicly available 510(k) Summary posted in this database. FDA notes
that our public database is a transparent tool allowing users to
confirm that their devices have been submitted under a new 510(k) and
demonstrated conformance to applicable special controls.
VI. Analysis of Environmental Impact
We have determined under 21 CFR 25.34(b) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VII. Paperwork Reduction Act of 1995
This administrative order establishes special controls that refer
to previously approved collections of information found in other FDA
regulations and guidance. Those collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The
collections of information in 21 CFR part 807, subpart E, have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 820 have been approved under OMB control
number 0910-0073; and the collections of information under 21 CFR part
801 have been approved under OMB control number 0910-0485.
VIII. Codification of Orders
Prior to the amendments by FDASIA, section 513(e) of the FD&C Act
provided for FDA to issue regulations to reclassify devices. Although
section 513(e) as amended requires FDA to issue final orders rather
than regulations, it also provides for FDA to revoke previously issued
regulations by order. FDA will continue to codify classifications and
reclassifications in the Code of Federal Regulations (CFR). Changes
resulting from final orders will appear in the CFR as changes to
codified classification determinations or as newly codified orders.
Therefore, under section 513(e)(1)(A)(i), as amended by FDASIA, in the
final order, we are revising 21 CFR 878.4800 to remove the
classification of surgical staplers and codifying surgical staplers in
the new 21 CFR 878.4740, under which surgical staplers for internal use
would be reclassified into class II and surgical staplers for external
use would remain in class I, exempt from premarket notification.
IX. References
The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500; and are available for viewing by interested persons between 9
a.m. and 4 p.m., Monday through Friday; they also are available
electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without
asterisks are not on public display at <a href="https://www.regulations.gov">https://www.regulations.gov</a>
because they have copyright restriction. Some may be available at the
website address, if listed. References without asterisks are available
for viewing only at the Dockets Management Staff. FDA has verified the
website addresses, as of the date this document publishes in the
Federal Register, but websites are subject to change over time.
*1. FDA, May 30, 2019, Meeting of the General and Plastic Surgery
Devices Panel Meeting Materials (available at <a href="https://www.fda.gov/advisory-committees/advisory-committee-calendar/may-30-31-2019-general-and-plastic-surgery-devices-panel-medical-devices-advisory-committee-meeting">https://www.fda.gov/advisory-committees/advisory-committee-calendar/may-30-31-2019-general-and-plastic-surgery-devices-panel-medical-devices-advisory-committee-meeting</a>).
2. Folkesson, J., J. Nilsson, L. P[aring]hlman, et al., ``The
Circular Stapling Device as a Risk Factor for Anastomotic Leakage.''
Colorectal Disease. 2004 July; 6(4):275-9.
3. Ouchi, A., A. Masahiko, K. Aono, et al., ``Staple-Line Recurrence
Arising 10 Years After Functional End-to-End Anastomosis for Colon
Cancer: A Case Report.'' Surgical Case Reports. 2015 December; 1:7.
4. Hsu, T.C. and M.J. Chen, ``Presence of Colon Carcinoma Cells at
the Resection Line May Cause Recurrence Following Stapling
Anastomosis.'' Asian Journal of Surgery. 2018 November; 41(6):569-
572.
*5. ``Guidance for Industry and Food and Drug Administration Staff:
Use of International Standard ISO 10993-1, `Biological Evaluation of
Medical Devices--Part 1: Evaluation and Testing Within a Risk
Management Process,' '' September 4, 2020, available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and</a>.
*6. ``Guidance for Industry and FDA Staff: The Least Burdensome
Provisions: Concept and Principles,'' February 5, 2019, available
at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles</a>.
*7. FDA, March 8, 2019, Letter to Health Care Providers, ``Safe Use
of Surgical Staplers and Staples,'' available at: <a href="https://www.fda.gov/medical-devices/letters-health-care-providers/safe-use-surgical-staplers-and-staples-letter-health-care-providers">https://www.fda.gov/medical-devices/letters-health-care-providers/safe-use-surgical-staplers-and-staples-letter-health-care-providers</a>.
*8. ``Guidance for Industry and Food and Drug Administration Staff:
Deciding When to Submit a 510(k) for a Change to an Existing
Device,'' October 25, 2017, available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device</a>.
9. Lee, S., B. Ahn, and S. Lee, ``The Relationship Between the
Number of Intersections of Staple Lines and Anastomotic Leakage
After the Use of a Double Stapling Technique in Laparoscopic
Colorectal Surgery.'' Surgical Laparoscopy, Endoscopy & Percutaneous
Techniques. 2017 August; 27(4):273-281.
10. Crafa, F., J. Megevand, G. Romano, and P. Sileri, ``New Double-
Stapled
[[Page 56204]]
Anastomotic Technique to Avoid Crossing Staple Lines.'' Techniques
in Coloproctology. 2015; 19: 319-320.
List of Subjects in 21 CFR Part 878
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 878 is amended as follows:
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
0
1. The authority citation for part 878 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 878.4740 to subpart E to read as follows:
Sec. 878.4740 Surgical stapler.
(a) Surgical stapler for external use.
(1) Identification. A surgical stapler for external use is a
specialized prescription device used to deliver compatible staples to
skin during surgery.
(2) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter, subject to the limitations in Sec. 878.9.
(b) Surgical stapler for internal use.
(1) Identification. A surgical stapler for internal use is a
specialized prescription device used to deliver compatible staples to
internal tissues during surgery for resection, transection, and
creating anastomoses.
(2) Classification. Class II (special controls). The special
controls for this device are:
(i) Performance testing must demonstrate that the stapler, when
used with compatible staples, performs as intended under anticipated
conditions of use. Performance testing must include the following:
(A) Evaluation of staple formation characteristics in the maximum
and minimum tissue thicknesses for each staple type;
(B) For manual staplers only, measurement of the worst-case
deployment pressures on stapler firing force;
(C) Measurement of staple line strength;
(D) Confirmation of staple line integrity; and
(E) In vivo confirmation of staple line hemostasis.
(ii) For powered staplers only, appropriate analysis/testing must
demonstrate the electromagnetic compatibility and electrical, thermal,
and mechanical safety of the device.
(iii) For powered staplers only, appropriate software verification,
validation, and hazard analysis must be performed.
(iv) Human factors testing must demonstrate that the clinician can
correctly select and safely use the device, as identified in the
labeling, based on reading the directions for use.
(v) The elements of the device that may contact the patient must be
demonstrated to be biocompatible.
(vi) Performance data must demonstrate the sterility of the device.
(vii) Validation of cleaning and sterilization instructions must
demonstrate that any reusable device components can be safely and
effectively reprocessed per the recommended cleaning and sterilization
protocol in the labeling.
(viii) Performance data must support the shelf life of the device
by demonstrating continued device functionality, sterility, and package
integrity over the identified shelf life.
(ix) Labeling of the device must include the following:
(A) Unless data demonstrates the safety of doing so,
contraindications must be identified regarding use of the device on
tissues for which the risk of stapling outweighs any reasonably
foreseeable benefit due to known complications, including the stapling
of tissues that are necrotic, friable, or have altered integrity.
(B) Unless available information demonstrates that the specific
warnings do not apply, the labeling must provide appropriate warnings
regarding how to avoid known hazards associated with device use
including:
(1) Avoidance of use of the stapler to staple tissue outside of the
labeled limits for maximum and minimum tissue thickness;
(2) Avoidance of obstructions to the creation of the staple line
and the unintended stapling of other anatomic structures;
(3) Avoidance of clamping and unclamping of delicate tissue
structures to prevent tissue damage;
(4) Avoidance of use of the stapler on the aorta;
(5) Establishing proximal control of blood vessels prior to
stapling where practical and methods of blood vessel control in the
event of stapler failure;
(6) Ensuring stapler compatibility with staples; and
(7) Risks specifically associated with the crossing of staple
lines.
(C) Specific user instructions for proper device use including
measures associated with the prevention of device malfunction, and
evaluation of the appropriateness of the target tissue for stapling.
(D) List of staples with which the stapler has been demonstrated to
be compatible.
(E) Identification of key performance parameters and technical
characteristics of the stapler and the compatible staples needed for
safe use of the device.
(F) Information regarding tissues on which the stapler is intended
to be used.
(G) Identification of safety mechanisms of the stapler.
(H) Validated methods and instructions for reprocessing of any
reusable device components.
(I) An expiration date/shelf life.
(x) Package labels must include critical information and technical
characteristics necessary for proper device selection.
0
3. In Sec. 878.4800, revise paragraph (a) to read as follows:
Sec. 878.4800 Manual surgical instrument for general use.
(a) Identification. A manual surgical instrument for general use is
a nonpowered, hand-held, or hand-manipulated device, either reusable or
disposable, intended to be used in various general surgical procedures.
The device includes the applicator, clip applier, biopsy brush, manual
dermabrasion brush, scrub brush, cannula, ligature carrier, chisel,
clamp, contractor, curette, cutter, dissector, elevator, skin graft
expander, file, forceps, gouge, instrument guide, needle guide, hammer,
hemostat, amputation hook, ligature passing and knot-tying instrument,
knife, blood lancet, mallet, disposable or reusable aspiration and
injection needle, disposable or reusable suturing needle, osteotome,
pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle,
one-piece scalpel, snare, spatula, disposable or reusable stripper,
stylet, suturing apparatus for the stomach and intestine, measuring
tape, and calipers. A surgical instrument that has specialized uses in
a specific medical specialty is classified in separate regulations in
parts 868 through 892 of this chapter.
* * * * *
Dated: October 4, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22041 Filed 10-7-21; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on October 8, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.