Proposed Rule2021-27137
Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures
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
December 15, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is proposing to classify spinal spheres for use in intervertebral fusion procedures (an unclassified, preamendments device) into class III for which FDA is separately proposing to require the filing of a premarket approval application (PMA). FDA has determined that general controls and special controls together are insufficient to provide reasonable assurance of safety and effectiveness for this device. FDA is publishing this proposed rule based, in part, on the recommendations of the Orthopaedic and Rehabilitation Devices Panel, regarding the classification of spinal spheres for use in intervertebral fusion procedures.
Full Text
<html>
<head>
<title>Federal Register, Volume 86 Issue 238 (Wednesday, December 15, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 238 (Wednesday, December 15, 2021)]
[Proposed Rules]
[Pages 71191-71196]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-27137]
[[Page 71191]]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. FDA-2021-N-0310]
RIN 0910-AI32
Medical Devices; Orthopedic Devices; Classification of Spinal
Spheres for Use in Intervertebral Fusion Procedures
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is proposing
to classify spinal spheres for use in intervertebral fusion procedures
(an unclassified, preamendments device) into class III for which FDA is
separately proposing to require the filing of a premarket approval
application (PMA). FDA has determined that general controls and special
controls together are insufficient to provide reasonable assurance of
safety and effectiveness for this device. FDA is publishing this
proposed rule based, in part, on the recommendations of the Orthopaedic
and Rehabilitation Devices Panel, regarding the classification of
spinal spheres for use in intervertebral fusion procedures.
DATES: Submit either electronic or written comments on the proposed
rule by March 15, 2022.
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 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-0310 for ``Medical Devices; Orthopedic Devices;
Classification of 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#adeec2c3ded9ccc3cec883fec2dbc8deedcbc9cc83c5c5de83cac2db"><span class="__cf_email__" data-cfemail="f3b09c9d8087929d9096dda09c859680b3959792dd9b9b80dd949c85">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Proposed Rule
B. Summary of the Major Provisions of the Proposed Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
A. Need for the Regulation
B. FDA's Current Regulatory Framework
C. History of This Rulemaking
IV. Legal Authority
V. Description of the Proposed Rule
A. Device Description
B. Risks to Health and Public Health Benefits
C. Proposed Classification and FDA's Findings
VI. Proposed Effective/Compliance Dates
VII. Preliminary Economic Analysis of Impacts
A. Introduction
B. Summary of Costs and Benefits
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References
[[Page 71192]]
I. Executive Summary
A. Purpose of the Proposed Rule
FDA is proposing to classify spinal spheres for use in
intervertebral fusion procedures (spinal spheres), which are
unclassified, preamendments devices, into class III. A spinal sphere is
a prescription device used to provide stabilization of a spinal segment
as an adjunct to fusion. FDA currently regulates these unclassified
devices as devices requiring premarket notification, with the product
code NVR.
FDA initiated the classification of spinal spheres by consulting
the Orthopaedic and Rehabilitation Devices Panel (the Panel). The Panel
recommended that spinal spheres be classified into class III because
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 these devices present a potential
unreasonable risk of illness or injury. FDA conducted its own analysis
as described below and agrees with the Panel's recommendation. As such,
FDA proposes to classify spinal spheres into class III. FDA is also
proposing, by proposed order published elsewhere in this issue of the
Federal Register, to require the filing of PMAs for such devices.
B. Summary of the Major Provisions of the Proposed Rule
This rule proposes to classify spinal spheres into class III. The
proposed rule, if finalized, would establish the identification and
classification for spinal spheres. In addition, FDA proposes that the
use of spinal spheres devices be limited to prescription use.
C. Legal Authority
The Agency is proposing this classification under the authority of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301).
Specifically, the relevant authority related to the proposed
classification includes section 513(a) through (d) of the FD&C Act (21
U.S.C. 360c(a) through (d)), regarding device classes, classification,
and panels, and section 515 (21 U.S.C. 360e), regarding PMAs.
D. Costs and Benefits
This proposed rule, if finalized, would classify spinal spheres for
use in intervertebral fusion procedures (an unclassified, preamendments
device) into class III for which FDA is separately proposing to require
the filing of a premarket approval application. The costs of the rule
include one-time costs associated with reading the proposed rule. FDA
is only able to identify the costs of this proposed rule. We estimate
that the present value of the costs of the rule are between $427 and
$20,480, with a primary estimate of $10,453. Annualizing over a 10-year
period at a discount rate of 3 percent, the costs of this proposed rule
are estimated to be between $29 and $1,377, with a primary estimate of
$703. Annualizing over a 10-year period at a discount rate of 7
percent, the costs of this proposed rule are estimated to be between
$40 and $1,933, with a primary estimate of $987.
II. Table of Abbreviations/Commonly Used Acronyms in This Document
Table 1--Abbreviations and Acronyms
--------------------------------------------------------------------------------------------------------------------------------------------------------
Abbreviation or acronym What it means
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k)..................................... Premarket Notification.
CoCrMo..................................... cobalt-chromium-molybdenum.
FDA........................................ Food and Drug Administration.
FD&C Act................................... Federal Food, Drug, and Cosmetic Act.
MAUDE...................................... FDA's Manufacturer and User Facility Device Experience database.
OMB........................................ Office of Management and Budget.
PMA........................................ Premarket Approval Application.
--------------------------------------------------------------------------------------------------------------------------------------------------------
III. Background
A. Need for the Regulation
Currently, spinal spheres are unclassified devices subject to
premarket notification (510(k)) under section 510(k) of the FD&C Act
(21 U.S.C. 360(k)). Until an unclassified device type has been formally
classified by regulation, marketing of new devices within this device
type requires FDA clearance of a 510(k). As described below, FDA
granted the first clearance for spinal spheres (K051320, September 9,
2005) based on documentation that demonstrated that these devices were
substantially equivalent to devices that were in commercial
distribution prior to passage of the Medical Device Amendments on May
28, 1976. Because the clinical evidence is limited, FDA is proposing to
classify spinal spheres into class III, subject to PMA.
B. FDA's Current Regulatory Framework
The FD&C Act (21 U.S.C. 301 et seq.), as amended by the Medical
Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295),
established a comprehensive system for the regulation of medical
devices intended for human use. Section 513 of the FD&C Act established
three categories (classes) of devices, reflecting the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness: Class I (general controls), class II (special controls),
and class III (premarket approval).
Section 513(a)(1) of the FD&C Act defines the three classes of
devices. Class I devices are those devices for which the general
controls of the FD&C Act (controls authorized by or under sections 501,
502, 510, 516, 518, 519, or 520 of the FD&C Act (21 U.S.C. 351, 352,
360, 360f, 360h, 360i, or 360j) or any combination of such sections)
are sufficient to provide reasonable assurance of safety and
effectiveness; or those devices for which insufficient information
exists to determine that general controls are sufficient to provide
reasonable assurance of safety and effectiveness or to establish
special controls to provide such assurance, but because the devices are
not purported or represented to be for a use in supporting or
sustaining human life or for a use which is of substantial importance
in preventing impairment of human health, and do not present a
potential unreasonable risk of illness or injury, are to be regulated
by general controls (section 513(a)(1)(A) of the FD&C Act). Class II
devices are those devices for which general controls by themselves are
insufficient to provide reasonable assurance of safety and
effectiveness, but for which there is sufficient information to
establish special controls to provide such assurance, including the
promulgation of performance standards, postmarket surveillance, patient
[[Page 71193]]
registries, development and dissemination of guidelines,
recommendations, and other appropriate actions the Agency deems
necessary to provide such assurance (section 513(a)(1)(B) of the FD&C
Act). Class III devices are those devices for which insufficient
information exists to determine that general controls (controls
authorized by or under sections 501, 502, 510, 516, 518, 519, or 520 of
the FD&C Act or any combination of such sections) and special controls
would provide a reasonable assurance of safety and effectiveness, and
are purported or represented for a use in supporting or sustaining
human life or for a use which is of substantial importance in
preventing impairment of human health, or present a potential
unreasonable risk of illness or injury (section 513(a)(1)(C) of the
FD&C Act).
Under section 513(d) of the FD&C Act, FDA refers to devices that
were in commercial distribution before the 1976 amendments as
``preamendments devices.'' FDA classifies these devices after the
Agency: (1) Receives a recommendation from a device classification
panel (an FDA advisory committee); (2) publishes the panel's
recommendation for comment, along with a proposed regulation
classifying the device; and (3) publishes a final regulation
classifying the device (section 513(d)(1) of the FD&C Act). 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 a final regulation order under
section 515(b) of the FD&C Act requiring premarket approval. FDA is
also proposing, by proposed order published elsewhere in this issue of
the Federal Register, to require the filing of PMAs for such devices.
After the enactment of the 1976 amendments, FDA undertook an effort
to identify and classify all preamendments devices in accordance with
section 513(d) of the FD&C Act. As part of this effort, 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 were not included in this action and were never
separately classified. FDA initiated the classification of spinal
spheres by holding a panel meeting on December 12, 2013, regarding the
classification of spinal spheres (Ref. 1).
C. History of This Rulemaking
As described previously, 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. Spinal
sphere devices, however, 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.
On December 12, 2013, FDA convened 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 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 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.
IV. Legal Authority
The Agency is proposing this classification under the authority of
the FD&C Act (21 U.S.C. 301). Specifically, the relevant authority
related to the proposed classification includes sections 513(a) through
(d), regarding device classes, classification, and panels; and section
515, regarding PMAs.
V. Description of the Proposed Rule
We are proposing to amend subpart D of 21 CFR part 888 by adding
Sec. 888.3085 to classify spinal spheres for use in intervertebral
fusion procedures in accordance with section 513(d) of the FD&C Act.
This proposed rule applies to spinal spheres for use in intervertebral
fusion procedures regulated under the product code NVR. This proposed
rule does not apply to spinal spheres intended for use in non-fusion
procedures, which are currently regulated as class III devices subject
to PMA requirements.
A. Device Description
A spinal sphere for use in intervertebral fusion procedures 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) 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.
B. Risks to Health and Public Health Benefits
In evaluating the risks to health associated with use of spinal
spheres, FDA considered information from the
[[Page 71194]]
2013 Orthopaedic and Rehabilitation Panel meeting, the adverse event
reports for spinal spheres in FDA's Manufacturer and User Facility
Device Experience (MAUDE) database, and published scientific
literature, which is discussed in FDA's executive summary for the Panel
meeting (Ref. 1). We also considered adverse event reports and
literature since that time, which is consistent with the prior
information that was analyzed for the Panel meeting.
FDA's review of the information in the MAUDE database, as presented
to the Panel, resulted in the identification of 21 unique Medical
Device Reports (MDRs) on spinal sphere devices. Of this total, 18 MDRs
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, for the purposes of the Panel, 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.
At the Panel, FDA identified the following risks to health
associated with spinal spheres that could result from device-related
adverse events, including implant breakage during implantation, device
migration and/or subsidence, removal/revision, pain, and neurological
impairment. The Panel agreed with the risks to health and emphasized
that there would likely be a significantly higher risk of revision or
clinical failure as compared to standard intervertebral body fusion
devices. Furthermore, the Panel noted that these risks to health may
arise from mechanical instability associated with placement of a
spherical implant inserted between the parallel vertebral endplates.
Additionally, the Panel acknowledged that the risks to health
identified for intervertebral body fusion devices would also apply to
spinal spheres (Ref. 1). These devices are similar in terms of
materials, placement, and insertion, and therefore spheres would also
carry similar risks as those already identified for intervertebral body
fusion devices. The risks to health associated with use of
intervertebral body fusion devices that contain bone grafting material
identified during their reclassification were infection, adverse tissue
reaction, pain and loss of function, soft tissue injury, vertebral
endplate injury, reoperation, and pseudarthrosis (i.e., non-union) (72
FR 32170, June 12, 2007).
FDA agrees with the Panel's recommendations to incorporate the
risks to health associated with intervertebral body fusion devices into
the list of risks to health FDA identified as associated with spinal
spheres to more completely capture the risks to health associated with
such devices. FDA notes that the risk of vertebral endplate injury as
described in the risks associated with intervertebral body fusion
devices also encompasses the risk of subsidence; therefore, we are not
listing subsidence as a unique risk to health for spinal spheres. Based
on this information, FDA has identified and proposes the following
risks to health for spinal spheres:
(1) 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.
(2) 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.
(3) 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.
(4) Adverse tissue reaction: The implantation of the spinal sphere
device will elicit a mild inflammatory reaction typical of a normal
foreign body 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.
(5) Soft tissue injury: Soft tissue injury could include injury to
major blood vessels, viscera, nerve roots, spinal cord, and cauda
equina.
(6) 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.
(7) Pseudarthrosis: Pseudarthrosis (i.e., non-union) signifies
failure of the bony fusion mass and results in persistent instability.
(8) 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.
(9) 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.
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. As described above, however,
FDA is not aware of evidence supporting the stated benefit of spinal
spheres for use in fusion procedures.
C. Proposed Classification and FDA's Findings
Based on FDA's experience with spinal spheres, the Panel's
recommendations, and other available
[[Page 71195]]
information, FDA is proposing to classify spinal spheres for use in
intervertebral fusion procedures into class III. FDA is proposing this
classification because FDA believes that insufficient information
exists to determine that general controls and special controls would
provide reasonable assurance of safety and effectiveness for such
devices and, based upon assessment of benefits and risks, these devices
present a potential unreasonable risk of illness or injury. Elsewhere
in this issue of the Federal Register, FDA is proposing through a
proposed order to require the filing of a PMA under section 515(b) of
the FD&C Act. The proposed order will only be finalized if and when FDA
finalizes this proposed rule classifying spinal spheres in class III.
VI. Proposed Effective/Compliance Dates
FDA proposes that any final rule, based on this proposed rule,
become effective 30 days after its date of publication in the Federal
Register.
If this proposed rule and related proposed order to require the
filing of a PMA are finalized, spinal spheres for use in intervertebral
fusion procedures are considered adulterated if a PMA is not filed with
FDA within 30 months after the classification of the device into class
III, and commercial distribution of the product must cease (see section
501(f)(1)(2)(B) of the FD&C Act). However, the product may be
distributed for investigational use only, if the requirements of the
investigational device exemptions regulations in 21 CFR part 812 are
met.
VII. Preliminary Economic Analysis of Impacts
A. Introduction
We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
believe that this proposed rule is not a significant regulatory action
as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the estimated costs imposed on any affected firm are
very low, we propose to certify that the proposed rule will not have a
significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $158 million, using the most current (2020) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.
B. Summary of Costs and Benefits
This proposed rule, if finalized would classify spinal spheres for
use in intervertebral fusion procedures (an unclassified, preamendments
device) into class III for which FDA is separately proposing to require
the filing of a PMA.
The costs of the proposed rule are summarized in table 2; we did
not quantify benefits for this proposed rule. The costs of the rule
include one-time costs associated with reading the proposed rule. The
present value of the costs of the rule are estimated to be between $427
and $20,480, with a primary estimate of $10,453. The annualized value
of the primary estimate of costs over 10 years at a 3 percent discount
rate is approximately $703. The annualized value of the primary
estimate of costs over 10 years at a 7 percent discount rate is
approximately $987.
Table 2--Summary of Benefits, Costs, and Distributional Effects of Proposed Rule
----------------------------------------------------------------------------------------------------------------
Units
------------------------------------
Category Primary Low High Discount Period Notes
estimate estimate estimate Year rate covered
dollars (percent) (years)
----------------------------------------------------------------------------------------------------------------
Benefits:
Annualized.............. .......... .......... .......... .......... 7 10
Monetized $millions/year .......... .......... .......... .......... 3 10
Annualized.............. .......... .......... .......... .......... 7 10
Quantified.............. .......... .......... .......... .......... 3 10
Qualitative............. .......... .......... .......... .......... ..........
Costs:
Annualized.............. $0.00099 $0.00004 $0.00193 2019 7 10
Monetized $millions/year 0.00070 0.00003 0.00138 2019 3 10
Annualized.............. .......... .......... .......... .......... 7 10
Quantified.............. .......... .......... .......... .......... 3 10
Qualitative............. .......... .......... .......... .......... .......... 10
Transfers:
Federal................. .......... .......... .......... .......... 7 10
Annualized.............. .......... .......... .......... .......... 3 10
Monetized $millions/year .......... .......... .......... .......... .......... 10
------------------------------------------------------------------------
From/To................. From:
To:
----------------------------------------------------------------------------------------------------------------
Other................... .......... .......... .......... .......... 7 10
Annualized.............. .......... .......... .......... .......... 3 ..........
Monetized $millions/year .......... .......... .......... .......... .......... 10
------------------------------------------------------------------------
[[Page 71196]]
From/To................. From:
To:
----------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal
Government: None.
Small Business: Costs
would not exceed 0.002
percent of average
small firm annual
revenues.
Wages: None.
Growth: None.
----------------------------------------------------------------------------------------------------------------
We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule (Ref. 3) and at <a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>.
VIII. 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.
IX. Paperwork Reduction Act of 1995
FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
X. Federalism
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this proposed rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we conclude that the rule does not contain policies that have
federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement is not required.
XI. Consultation and Coordination With Indian Tribal Governments
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
determined that the rule does not contain policies that would have a
substantial direct effect on one or more Indian Tribes, on the
relationship between the Federal Government and Indian Tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian Tribes. The Agency solicits comments from tribal
officials on any potential impact on Indian Tribes from this proposed
action.
XII. 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/7993/20170405192244/https:/www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/ucm352525.htm">https://wayback.archive-it.org/7993/20170405192244/https:/www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/ucm352525.htm</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.
3. * FDA's full preliminary analysis of economic impacts is
available in the Docket No. FDA-2021-N-0310 for this proposed rule
and at <a href="https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm">https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm</a>.
List of Subjects in 21 CFR Part 888
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic
Act<INF>,</INF> 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. Add Sec. 888.3085 to subpart D to read as follows:
Sec. 888.3085 Spinal spheres for use in intervertebral fusion
procedures.
(a) Identification. 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.
(b) Classification. Class III.
Dated: December 9, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27137 Filed 12-14-21; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on December 15, 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.