Document ID: FDA-2021-N-0309-0001
Agency: fda
Document Type: Proposed Rule
Title: Effective Date of Requirement for
Premarket Approval Applications for
Spinal Spheres for Use in
Intervertebral Fusion Procedures
Posted Date: 2021-12-15T05:00Z

[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 [www.gpo.gov]
[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 https://www.regulations.gov 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at the Dockets Management Staff office between 
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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, [email protected].

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 https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov 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 
https://wayback.archive-it.org/7993/20170114044038/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM378083.pdf.
    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