[Federal Register Volume 88, Number 61 (Thursday, March 30, 2023)]
[Rules and Regulations]
[Pages 18987-18990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06566]


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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, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing a 
final rule to classify spinal spheres for use in intervertebral fusion 
procedures (an unclassified, preamendments device) into class III for 
which FDA is separately requiring 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.

DATES: This rule is effective May 1, 2023.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this final rule, 
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: 

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. History of This Rulemaking
    B. Summary of Comments to the Proposed Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. Description of Comments and FDA Response
VI. Effective/Compliance Dates
VII. 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. Reference

I. Executive Summary

A. Purpose of the Final Rule

    FDA is classifying spinal spheres for use in intervertebral fusion 
procedures (spinal spheres), which are unclassified, preamendments 
devices, into class III. A

[[Page 18988]]

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. The classification of spinal spheres was 
consistent with the recommendation of the Orthopaedic and 
Rehabilitation Devices Panel meeting held on December 12, 2013 (the 
Panel) and our consideration and analysis of public comments received 
following the publication of the proposed rule. FDA is also, by final 
order published elsewhere in this issue of the Federal Register, 
requiring the filing of PMAs for such devices.

B. Summary of the Major Provisions of the Final Rule

    This rule establishes the identification and classification for 
spinal spheres as class III devices. In addition, the use of spinal 
spheres devices is limited to prescription use.

C. Legal Authority

    The Agency is issuing this rule 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 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 rule classifies spinal spheres for use in intervertebral 
fusion procedures (an unclassified, preamendments device) into class 
III for which FDA is separately requiring the filing of a PMA. The 
costs of the rule include one-time costs associated with reading the 
rule. FDA is only able to identify the costs of this rule. We estimate 
that the present value of the costs of the rule are between $335 and 
$16,093, with a primary estimate of $8,214. Annualizing over a 10-year 
period at a discount rate of 3 percent, the costs of this rule are 
estimated to be between $23 and $1,082, with a primary estimate of 
$552. Annualizing over a 10-year period at a discount rate of 7 
percent, the costs of this rule are estimated to be between $32 and 
$1,519, with a primary estimate of $775.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

                   Table 1--Abbreviations and Acronyms
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       Abbreviation or acronym                   What it means
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510(k)..............................  Premarket Notification.
FDA.................................  Food and Drug Administration.
FD&C Act............................  Federal Food, Drug, and Cosmetic
                                       Act.
PMA.................................  Premarket Approval Application.
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III. Background

A. History of This Rulemaking

    In the Federal Register of December 15, 2021 (86 FR 71191) FDA 
issued a proposed rule to classify spinal spheres for use in 
intervertebral fusion procedures (an unclassified, preamendments 
device) into class III for which FDA requires the filing of a PMA and 
invited interested persons to comment on the proposed regulation by 
March 15, 2022. These proposals were consistent with feedback received 
from the Panel meeting held on December 12, 2013.

B. Summary of the Comments to the Proposed Rule

    FDA received two comments on the proposed rule--one from academia 
and another from an anonymous source. The comments were supportive of 
the classification of spinal spheres into class III as stated in the 
proposed rule and no changes were made in response to the comments in 
the final rule.

IV. Legal Authority

    We are issuing this final rule under the authority of the FD&C Act 
(21 U.S.C. 301). Specifically, the relevant authority related to the 
classification includes sections 513(a) through (d), regarding device 
classes, classification, and panels; and section 515, regarding PMAs.

V. Comments on the Proposed Rule and FDA Response

A. Introduction

    We received a few comment letters on the proposed rule by the close 
of the comment period. We received comments from academia and from an 
anonymous source. We describe and respond to the comments in section 
V.B of this document.

B. Description of Comments and FDA Response

    Both commenters supported FDA's proposed classification of spinal 
spheres for use in intervertebral fusion procedures (an unclassified, 
preamendments device) into class III for which FDA would require the 
filing of a PMA. The academic commenter agreed with FDA's assessment 
that this device type poses ``a potential unreasonable risk of illness 
or injury.'' The commenter described negative patient outcomes as 
reported in the literature and noted that classification of these 
devices into class III will safeguard patients undergoing spine surgery 
from a potentially devastating process and prevent the sale of a risky, 
unproven device.
    Additionally, another commenter stated that strong evidence is 
necessary to demonstrate the medical benefits of this device type prior 
to subjecting patients to the risks associated with these devices.
    We agree with both commenters supporting classification of spinal 
spheres to class III because there is 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 an unreasonable risk of illness or injury. As described in the 
preamble to the proposed rule, the risks to health from spinal spheres 
include 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 is not making any changes in the final 
rule in response to these comments.
    In the final rule, we are revising the section number from Sec.  
888.3085 (21 CFR 888.3085) to 21 CFR 888.3083, because a De Novo was 
previously granted under Sec.  888.3085. No other substantive changes 
were made to the regulation.

VI. Effective/Compliance Dates

    This final rule will become effective 30 days after its date of 
publication in the Federal Register.
    After this rule and related order to require the filing of a PMA 
are effective, spinal spheres for use in intervertebral fusion 
procedures will be 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)(2)(B) of the FD&C Act (21 U.S.C. 351(f)(2)(B))). 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.

[[Page 18989]]

VII. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the final 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 final 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 certify that the final 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 issuing ``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 $165 
million, using the most current (2021) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.

B. Summary of Costs and Benefits

    This final rule classifies spinal spheres for use in intervertebral 
fusion procedures (an unclassified, preamendments device) into class 
III for which FDA is separately issuing an order to require the filing 
of a PMA.
    The costs of the final rule are summarized in table 2; we did not 
quantify benefits for this rule. The costs of the rule include one-time 
costs associated with reading and understanding the rule. The present 
value of the costs of the rule are estimated to be between $335 and 
$16,093, with a primary estimate of $8,214. The annualized value of the 
primary estimate of costs over 10 years at a 3 percent discount rate is 
approximately $552. The annualized value of the primary estimate of 
costs over 10 years at a 7 percent discount rate is approximately $775.

                                       Table 2--Summary of Benefits, Costs, and Distributional Effects of the Rule
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                                                                                                  Units
                                                                                  ------------------------------------
                   Category                      Primary       Low        High                               Period                  Notes
                                                estimate    estimate    estimate      Year      Discount     covered
                                                                                     dollars    rate (%)     (years)
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Benefits:
    Annualized Monetized $millions/year......  ..........  ..........  ..........  ..........           7          10
                                                                                                        3          10
    Annualized Quantified....................  ..........  ..........  ..........  ..........           7          10
                                                                                                        3          10
    Qualitative..............................  ..........  ..........  ..........  ..........  ..........  ..........
Costs:
    Annualized Monetized $millions/year......     $0.0008    $0.00003      $0.002        2021           7          10
                                                   0.0006     0.00002       0.001        2021           3          10
    Annualized Quantified....................  ..........  ..........  ..........  ..........           7          10
                                                                                                        3          10
    Qualitative..............................  ..........  ..........  ..........  ..........  ..........          10
Transfers:
    Federal Annualized Monetized $millions/    ..........  ..........  ..........  ..........           7          10
     year.                                                                                              3          10
                                              ----------------------------------------------------------------------------------------------------------
    From/To..................................  From:
                                               To:
                                              ----------------------------------------------------------------------------------------------------------
    Other Annualized Monetized $millions/year  ..........  ..........  ..........  ..........           7          10
                                                                                                        3          10
                                              ----------------------------------------------------------------------------------------------------------
    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........................................................................................................................................
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    We have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the final rule. The full analysis of economic 
impacts is available in the docket for this final rule (Ref. 1) and at 
https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

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

    This final 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 final rule in accordance with the principles 
set forth in Executive Order 13132. We have determined that the 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

[[Page 18990]]

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 rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that would have substantial direct effects 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. 
Accordingly, we conclude that the rule does not contain policies that 
have tribal implications as defined in the Executive order and, 
consequently, a tribal summary impact statement is not required.

XII. Reference

    The following reference is on display at the Dockets Management 
Staff (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at https://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. FDA's full analysis of economic impacts is available in the 
Docket No. FDA-2021-N-0310 for this rule and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

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, 21 CFR 
part 888 is 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.  888.3083 to subpart D to read as follows:


Sec.  888.3083  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: March 17, 2023.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2023-06566 Filed 3-29-23; 8:45 am]
BILLING CODE 4164-01-P