Proposed Rule2021-27139
Effective Date of Requirement for Premarket Approval Applications for Spinal Spheres for Use in Intervertebral Fusion Procedures
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Published
December 15, 2021
Issuing agencies
Health and Human Services Department
Abstract
The Food and Drug Administration (FDA or Agency) is proposing to require the filing of a premarket approval application (PMA) for spinal spheres for use in intervertebral fusion procedures, which is an unclassified, preamendments device. FDA is summarizing its proposed findings regarding the degree or risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the PMA requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the benefits to the public from the use of the device.
Full Text
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<title>Federal Register, Volume 86 Issue 238 (Wednesday, December 15, 2021)</title>
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[Federal Register Volume 86, Number 238 (Wednesday, December 15, 2021)]
[Proposed Rules]
[Pages 71197-71201]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-27139]
[[Page 71197]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. FDA-2021-N-0309]
Effective Date of Requirement for Premarket Approval Applications
for Spinal Spheres for Use in Intervertebral Fusion Procedures
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Proposed amendment; proposed order.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is proposing
to require the filing of a premarket approval application (PMA) for
spinal spheres for use in intervertebral fusion procedures, which is an
unclassified, preamendments device. FDA is summarizing its proposed
findings regarding the degree or risk of illness or injury designed to
be eliminated or reduced by requiring the device to meet the PMA
requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and
the benefits to the public from the use of the device.
DATES: Submit either electronic or written comments on the proposed
order by March 15, 2022. FDA intends that, if a final order based on
this proposed order is issued, anyone who wishes to market spinal
spheres for use in intervertebral fusion procedures will need to submit
a PMA prior to the last day of the 30th calendar month beginning after
the month in which the classification of the device in class III became
effective. See section III for the effective date of any final order
that may publish based on this proposed order. See section VI of this
document for more information about submitting a PMA.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 15, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 15, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions.'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2021-N-0309 for ``Effective Date of Requirement for Premarket
Approval Applications for Spinal Spheres for Use in Intervertebral
Fusion Procedures.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff office between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Constance Soves, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1656, Silver Spring, MD 20993-0002, 301-
796-6951, <a href="/cdn-cgi/l/email-protection#7a391514090e1b14191f5429150c1f093a1c1e1b54121209541d150c"><span class="__cf_email__" data-cfemail="14577b7a6760757a77713a477b627167547270753a7c7c673a737b62">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background--Regulatory Authorities
The 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 on May 28, 1976 of the
1976 amendments
[[Page 71198]]
(Medical Device Amendments of 1976, Pub. L. 94-295), (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.
A person may market a preamendments device that has been classified
into class III through premarket notification procedures, without
submission of a PMA until FDA issues an administrative order under
section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket
approval.
Section 515(f) of the FD&C Act provides an alternative pathway for
meeting the premarket approval requirement. Under section 515(f),
manufacturers may meet the premarket approval requirement, if they file
a notice of completion of a product development protocol (PDP) approved
under section 515(f)(4) of the FD&C Act and FDA declares the PDP
completed under section 515(f)(6)(B) of the FD&C Act. Accordingly, the
manufacturer of a preamendments class III device may comply with a call
for PMAs by filing a PMA or a notice of completion of a PDP. In
practice, however, the option of filing a notice of completion of a PDP
has rarely been used. For simplicity, although the PDP option remains
available to manufacturers in response to a final order under section
515(b) of the FD&C Act, this document will refer only to the
requirement for filing and obtaining approval of a PMA.
Section 515(b)(1) of the FD&C Act sets forth the process for
issuing a final order. Specifically, prior to the issuance of a final
order requiring premarket approval for a preamendments class III
device, the following must occur: (1) Publication of a proposed 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 from all affected stakeholders, including patients, payors,
and providers.
Section 515(b)(2) of the FD&C Act provides that a proposed order to
require premarket approval shall contain: (1) The proposed order; (2)
proposed findings with respect to the degree of risk of illness or
injury designed to be eliminated or reduced by requiring the device to
have an approved PMA and the benefit to the public from the use of the
device; (3) an opportunity for the submission of comments on the
proposed order and the proposed findings; and (4) an opportunity to
request a change in the classification of the device based on new
information relevant to the classification of the device.
Section 515(b)(3) of the FD&C Act provides that FDA shall, after
the close of the comment period on the proposed order,\1\ consideration
of any comments received, and a meeting of a device classification
panel described in section 513(b) of the FD&C Act, issue a final order
to require premarket approval or publish a document terminating the
proceeding together with the reasons for such termination. If FDA
terminates the proceeding, FDA is required to initiate reclassification
of the device under section 513(e) of the FD&C Act, unless the reason
for termination is that the device is a banned device under section 516
of the FD&C Act (21 U.S.C. 360f).
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\1\ In December 2019, FDA began adding the term ``Proposed
amendment'' to the ``ACTION'' caption for these documents to
indicate that they ``propose to amend'' the Code of Federal
Regulations. This editorial change was made in accordance with the
Office of the Federal Register's 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.
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A preamendments class III device may be commercially distributed
without a PMA until 90 days after FDA issues a final order requiring
premarket approval for the device, or 30 months after the
classification of the device in class III under section 513 of the FD&C
Act becomes effective, whichever is later (section 501(f)(2)(B) of the
FD&C Act (21 U.S.C. 351(f)(2)(B)). Elsewhere in this issue of the
Federal Register, FDA is proposing to classify spinal spheres for use
in intervertebral fusion procedures (spinal spheres) to class III.
Therefore, if the proposed classification regulation and the order to
require PMAs are finalized at the same time, a PMA for spinal spheres
for use in intervertebral fusion procedures must be filed within the
30-month period because that will be the later of the two time periods.
If a PMA is not timely filed for such devices, then the device would be
deemed adulterated under section 501(f) of the FD&C Act.
Also, a preamendments device subject to the order process under
section 515(b) of the FD&C Act is not required to have an approved
investigational device exemption (IDE) (see part 812 (21 CFR part 812))
contemporaneous with its interstate distribution until the date
identified by FDA in the final order requiring the filing of a PMA for
the device. At that time, an IDE is required only if a PMA has not been
filed. If the manufacturer, importer, or other sponsor of the device
submits an IDE application and FDA approves it, the device may be
distributed for investigational use. If a PMA is not filed by the later
of the two dates, and the device is not distributed for investigational
use under an IDE, the device is deemed adulterated within the meaning
of section 501(f)(1)(A) of the FD&C Act and subject to enforcement
action.
II. Regulatory History of the Devices
After the enactment of the Medical Device Amendments of 1976, FDA
undertook an effort to identify and classify all preamendments devices,
in accordance with section 513(d) of the FD&C Act. FDA issued a
proposed rule for classification of 77 generic types of orthopedic
devices in the Federal Register of September 4, 1987 (52 FR 33686).
However, spinal spheres for use in intervertebral fusion procedures
were not identified in this effort. Subsequently and consistent with
the FD&C Act, FDA held a panel meeting on December 12, 2013, regarding
the classification of spinal sphere devices for use in intervertebral
fusion procedures (Ref. 1). Spinal sphere devices, intended for use in
fusion procedures, are no longer used due to the widespread adoption of
intervertebral body fusion devices (``interbody cages''). Unlike spinal
sphere devices, interbody cages generally possess different features to
engage with vertebral endplates, allowing them to resist migration and
subsidence, and features that allow for the packing of graft material,
facilitating bone growth into and through the device.
Elsewhere in this issue of the Federal Register, FDA is proposing
to classify unclassified, preamendment spinal spheres for use in
intervertebral fusion procedures into class III. A PMA, in addition to
general controls, will provide reasonable assurance of the safety and
effectiveness of the device. The proposed rule would also establish the
identification, classification, and regulatory controls for spinal
spheres.
Spinal spheres for use in intervertebral fusion procedures are
unclassified preamendments devices. These devices have been subject to
premarket review through a 510(k) submission and have been cleared for
marketing if FDA considers the device to be substantially equivalent to
a legally marketed predicate in accordance with section 513(i) of the
FD&C Act. To date, FDA has cleared six spinal sphere devices from four
manufacturers.
[[Page 71199]]
On December 12, 2013, FDA convened the Orthopaedic and
Rehabilitation Devices Panel (the Panel) to secure recommendations
regarding the appropriate classification, regulatory controls, as well
as risks to health and benefits of spinal spheres (Ref. 1). At the
meeting, FDA requested that the Panel consider whether this device type
fits the statutory definition for a class III device. The Panel
considered the information provided by FDA about spinal spheres,
including results and analysis from a literature search and search of
known adverse events (Ref. 1).
The Panel unanimously recommended that spinal spheres be classified
into class III, subject to PMA. The Panel believed that classification
in class III is appropriate given that there was a lack of available
evidence to determine that general and special controls are sufficient
to provide reasonable assurance of its safety and effectiveness for use
in intervertebral body fusion procedures. Furthermore, the Panel
unanimously agreed that spinal spheres for use in fusion procedures
present an unreasonable risk of illness or injury to the patients. In
addition to the risks to health identified by FDA that include removal/
revision, pain, and neurologic impairment, the Panel recommended
incorporating all known risks generally associated with spinal
interbody fusion procedures (see Ref. 1, Panel transcript at page 58).
In summary, the Panel unanimously determined that given the lack of
available evidence and unreasonable risk profile of spinal spheres
devices for use in fusion procedures, these devices should be
classified as class III devices, which would, after publication of a
final order calling for PMAs, require submission of a PMA application
and approval to market the device. FDA agrees with the Panel's
recommendation that there was a lack of available evidence to determine
that general and special controls are sufficient to provide reasonable
assurance of its safety and effectiveness, and that the device presents
a potential unreasonable risk of illness or injury. FDA further agrees
with the Panel's recommendation that spinal sphere devices for use in
fusion procedures be classified into class III subject to PMA.
III. Dates New Requirements Apply
If FDA finalizes the proposed classification of spinal spheres,
these devices will be classified into class III. In accordance with
sections 501(f)(2)(B) and 515(b) of the FD&C Act, FDA is proposing to
require that a PMA be filed with the Agency for spinal sphere devices
by the last day of the 30th calendar month beginning after the month in
which the classification of the device in class III became effective.
An applicant whose product was legally in commercial distribution
before May 28, 1976, or whose product has been found to be
substantially equivalent to such a product, will be permitted to
continue marketing such class III product during FDA's review of the
PMA, provided that a PMA is timely filed. FDA intends to review any PMA
for the device within 180 days. FDA cautions that under section
515(d)(1)(B)(i) of the FD&C Act, the Agency may not enter into an
agreement to extend the review period for a PMA beyond 180 days, unless
the Agency finds that ``. . . the continued availability of the device
is necessary for the public health.''
If a PMA for a class III device is not filed with FDA within 30
months after the classification of the device into class III,
commercial distribution of the device must cease. The device may be
distributed for investigational use, only if the requirements of the
IDE regulations in part 812 are met. The requirements for
investigational use of significant risk devices include submitting an
IDE application to FDA for review and approval. An approved IDE is
required to be in effect before an investigation of the device may be
initiated or continued under 21 CFR 812.30. FDA, therefore, recommends
that IDE applications be submitted to FDA at least 30 days before the
date a PMA is required to be filed to avoid interrupting
investigations.
IV. Device Subject to This Proposal
A spinal sphere is a prescription device that is an implanted,
solid, spherical device manufactured from metallic (e.g., cobalt-
chromium-molybdenum (CoCrMo)) or polymeric (e.g., polyetheretherketone
(PEEK)) materials. They are intended to be inserted into the
intervertebral disc space of the lumbar spine following a discectomy in
order to maintain disc space height and provide postoperative
stabilization to the affected spinal segment during fusion procedures.
The device is to be used with bone graft material. FDA currently
regulates these unclassified devices as devices requiring a 510(k)
submission under product code NVR.
Elsewhere in this issue of the Federal Register, FDA is proposing
to classify spinal spheres in class III and identifies these devices as
follows: A spinal sphere device is an implanted, solid, spherical,
prescription device manufactured from metallic or polymeric materials.
The device is inserted into the intervertebral body space of the lumbar
spine to provide stabilization and to help promote intervertebral body
fusion. The device is to be used with bone graft material.
In accordance with section 515(b)(2)(D) of the FD&C Act, interested
persons are being offered the opportunity to comment or request a
change on the Agency's proposed classification of spinal spheres based
on new information published elsewhere in this Federal Register.
V. Proposed Findings With Respect to Risks and Benefits for Spinal
Spheres for Use in Intervertebral Fusion Procedures
As required by section 515(b) of the FD&C Act, FDA is publishing
its proposed findings regarding: (1) The degree of risk of illness or
injury designed to be eliminated or reduced by requiring that these
devices have an approved PMA and (2) the benefits to the public from
the use of the devices. These findings are based on the reports and
recommendations of the Orthopaedic and Rehabilitation Devices Panel
meeting on December 12, 2013 (Ref. 1), and any additional information
that FDA has obtained. Additional information regarding the risks can
be found below, as well as in the proposed rule published elsewhere in
this issue of the Federal Register, proposing to classify these devices
into class III.
Based on this information, FDA has identified and proposes the
following risks to health for spinal spheres:
Reoperation: The need for reoperation could result from a failed
spinal sphere device or component of the device, from nerve root
decompression or adjacent level disease, or from reasons related to any
surgery, e.g., infection or bleeding.
Pain and loss of function: Some device-related complications that
may cause pain and loss of function include device fracture,
deformation, loosening, or extrusion. The wear of materials, which may
cause osteolysis (dissolution of bone), and component disassembly,
fracture, or failure may also result in pain and loss of function.
Infection: Infection of the soft tissue, bony tissue, and the disc
space may arise due to implantation of a spinal sphere device. Material
composition or impurities, wear debris, operative time, and operative
environment may compromise the vascular supply to the area or affect
the immune system, which could increase the risk of infection. Improper
sterilization or packaging may also increase the risk of infection.
Adverse tissue reaction: The implantation of the spinal sphere
device will elicit a mild inflammatory reaction typical of a normal
foreign body
[[Page 71200]]
response. Incompatible materials or impurities in the materials and
wear debris may increase the severity of a local tissue reaction or
cause a systemic tissue reaction. If the materials used in the
manufacture of the spinal sphere device are not biocompatible, the
patient could have an adverse tissue reaction.
Soft tissue injury: Soft tissue injury could include injury to
major blood vessels, viscera, nerve roots, spinal cord, and cauda
equina.
Vertebral endplate injury: Surgically inserting a device with a
different geometry and modulus of elasticity than bone may lead to
vertebral fracture, sinking of the device into the vertebral endplate
(subsidence), collapse of the local blood supply, and collapse of the
vertebral end plate.
Pseudarthrosis: Pseudarthrosis (i.e., non-union) signifies failure
of the bony fusion mass and results in persistent instability.
Implant migration and/or instability: The spinal sphere device may
not adequately stabilize the disc space and may migrate out of its
intended placement as it is a spherical implant inserted between the
parallel vertebral endplates. This may lead to subsequent adverse
clinical sequelae, such as pain or loss of function or pseudarthrosis.
Implant breakage during insertion: The device may fracture during
implantation, which could result in a mechanical or functional failure.
This may lead to subsequent adverse clinical sequelae, such as
neurologic, vascular, or osseous injury.
A. Summary of Data
FDA conducted queries of the Manufacturer and User Facility Device
Experience (MAUDE) database to identify adverse events related to use
of spinal spheres. The queries resulted in the identification of 21
unique Medical Device Reports (MDRs) on spinal sphere devices at the
time of the Panel meeting. Of these 21 MDRS, 18 were reported as
injuries and 3 as malfunctions. Three additional MDRs have been
reported under this product code since the previous review of the MAUDE
database prior to the Panel meeting. One report reflects use of a
spinal sphere device without fusion that was also reported in the
literature as discussed below. One report was regarding devices that
were not spinal spheres, and the remaining report was unclear on the
device that caused the event.
Additionally, FDA conducted a comprehensive literature review to
identify and gather relevant published information regarding the safety
and effectiveness of spinal sphere devices for use in fusion
procedures. However, no references specifically describing spinal
sphere devices for use in fusion procedures were identified. A
contemporary search using the same parameters yielded a similar result.
Of note, one article, a case study of a patient implanted with a spinal
sphere, reflected one of the MDRs reported above; however, this patient
did not undergo spinal fusion in conjunction with implantation of the
device (Ref. 2). Consequently, FDA concludes there is inadequate
information characterizing the safety and effectiveness of spinal
sphere devices when used for fusion procedures. The 510(k) clearances
of these devices were based solely on nonclinical information and
determinations of substantial equivalence to the preamendments device
in accordance with section 513(i) of the FD&C Act, which, in light of
the available information regarding the risks with no information
supporting the benefit of these devices, is inadequate to support a
reasonable assurance of safety and effectiveness for these devices.
Subsequently, on December 12, 2013, FDA convened the Orthopaedic
and Rehabilitation Panel described in section I (Ref. 1). The Panel
unanimously concluded that there was a lack of available evidence to
determine that general and special controls are sufficient to provide
reasonable assurance of its safety and effectiveness for spinal sphere
devices for use in fusion procedures. Furthermore, the Panel
unanimously agreed that because spinal sphere devices for use in fusion
procedures present an unreasonable risk of illness or injury to the
patient given the lack of probable benefit, spinal spheres should be
classified into class III.
B. Benefits of the Device
The purported benefit of use of spinal spheres for use in
intervertebral fusion procedures is to provide stabilization of a
spinal segment, as an adjunct to fusion; however, FDA is not aware of
evidence supporting the stated benefit of spinal spheres for use in
fusion procedures. FDA is proposing a PMA be filed to require that
manufacturers demonstrate that a reasonable assurance of safety and
effectiveness exists for spinal spheres.
C. Risks to Health
The Panel unanimously determined that there was a lack of available
evidence to determine that general and special controls are sufficient
to provide reasonable assurance of its safety and effectiveness, and
that the device presents a potential unreasonable risk of illness or
injury. The unreasonable risk profile of spinal spheres devices for use
in fusion procedures includes reoperation, pain and loss of function,
infection, adverse tissue reaction, soft tissue injury, vertebral
endplate injury, pseudarthrosis, implant migration and/or instability,
and implant breakage during insertion. FDA agrees with the Panel's
recommendation that insufficient information exists FDA further agrees
with the Panel's recommendation that spinal sphere devices for use in
fusion procedures be classified into class III subject to PMA.
VI. PMA Requirements
A PMA for spinal sphere devices for use in fusion procedures must
include the information required by section 515(c)(1) of the FD&C Act.
Such a PMA should also include a detailed discussion of the risks
identified in section V, as well as a discussion of the effectiveness
of the product for which premarket approval is sought. In addition, a
PMA must include all data and information on the following: (1) Any
risks known, or that should be reasonably known, to the applicant that
have not been identified in this document; (2) the effectiveness of the
device that is the subject of the application; and (3) full reports of
all preclinical and clinical information from investigations on the
safety and effectiveness of the device for which premarket approval is
sought.
A PMA must include valid scientific evidence to demonstrate
reasonable assurance of the safety and effectiveness of the spinal
sphere for its intended use (see Sec. 860.7(c)(2) (21 CFR
860.7(c)(2))). FDA defines valid scientific evidence in Sec.
860.7(c)(2).
To present reasonable assurance of safety and effectiveness of
spinal sphere devices, FDA tentatively concludes that manufacturers
should submit performance testing, including clinical trials of their
product, in order to support PMA approval. Existing published clinical
literature relevant to the product may also be leveraged as part of the
PMA submission. In addition, FDA strongly encourages manufacturers to
meet with the Agency early through the Q-Submission Program for any
assistance in preparation of their PMA.
VII. 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
[[Page 71201]]
environmental impact statement is required.
VIII. Paperwork Reduction Act of 1995
While this proposed order contains no collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by the OMB under the PRA. The
collections of information in 21 CFR part 814, subparts A through E,
have been approved under OMB control number 0910-0231; and the
collections of information in part 812 have been approved under OMB
control number 0910-0078.
IX. Proposed Effective Date
FDA is proposing that any final order based on this proposal become
effective on the date of its publication in the Federal Register or at
a later date if stated in the final order.
X. Opportunity To Request a Change in Classification
Before requiring the filing of a PMA or notice of completion of a
PDP for a device, FDA is required by section 515(b)(2)(D) of the FD&C
Act to provide an opportunity for interested persons to request a
change in the classification of the device based on new information
relevant to the classification. A request for a change in the
classification of spinal spheres for use in intervertebral fusion
procedures should be provided in response to the proposed rule issued
elsewhere in this issue of the Federal Register and contain the
information required by 21 CFR 860.123, including new information
relevant to the classification of the device.
XI. References
The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) 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. *Orthopaedic and Rehabilitation Devices Panel--Classification
of Spinal Sphere Devices Meeting, December 12, 2013, available at
<a href="https://wayback.archive-it.org/7993/20170114044038/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM378083.pdf">https://wayback.archive-it.org/7993/20170114044038/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM378083.pdf</a>.
2. Lindley, E.M., B. Levy, E.L. Burger, et al., ``Failure of the
Fernstrom Ball in Contemporary Spine Surgery: A Case of History
Repeating Itself.'' Current Orthopaedic Practice, 25(1): 87-91,
2014.
List of Subjects in 21 CFR Part 888
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, we
propose that 21 CFR part 888 be amended as follows:
PART 888--ORTHOPEDIC DEVICES
0
1. The authority citation for part 888 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. In Sec. 888.3085, add paragraph (c) to read as follows:
Sec. 888.3085 Spinal spheres for use in intervertebral fusion
procedures.
* * * * *
(c) Date premarket approval application (PMA) or notice of
completion of product development protocol (PDP) is required. A PMA or
notice of completion of a PDP is required to be filed with the Food and
Drug Administration on or before [A DATE WILL BE ADDED ON THE LAST DAY
OF THE 30TH FULL CALENDAR MONTH AFTER THE FUTURE FINAL REGULATION THAT
CLASSIFIES THE DEVICE INTO CLASS III IS EFFECTIVE], for any spinal
sphere for use in intervertebral fusion procedures as identified in
paragraph (a) of this section that was in commercial distribution
before May 28, 1976, or that has, on or before [A DATE WILL BE ADDED ON
THE LAST DAY OF THE 30TH FULL CALENDAR MONTH AFTER THE FUTURE FINAL
REGULATION THAT CLASSIFIES THE DEVICE INTO CLASS III IS EFFECTIVE],
been found to be substantially equivalent to any spinal sphere device
for use in intervertebral fusion procedures identified in paragraph (a)
of this section, that was in commercial distribution before May 28,
1976. Any other spinal sphere device for use in an intervertebral
fusion procedure identified in paragraph (a) of this section shall have
an approved PMA or declared completed PDP in effect before being placed
in commercial distribution.
Dated: December 9, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27139 Filed 12-14-21; 8:45 am]
BILLING CODE 4164-01-P
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