Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures, 18987-18990 [2023-06566]
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Federal Register / Vol. 88, No. 61 / Thursday, March 30, 2023 / Rules and Regulations
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an editorial or technical error that
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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.
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
lllllllllllllllllllll filing of a premarket approval
application (PMA). FDA has determined
(Signature)
lllllllllllllllllllll that general controls and special
controls together are insufficient to
(Name and title)
lllllllllllllllllllll provide reasonable assurance of safety
and effectiveness for this device.
(Date)
DATES
: This rule is effective May 1,
Instruction to Signature: The
2023.
statement must be signed by the filing
person or that person’s authorized
ADDRESSES: For access to the docket to
representative. If the statement is signed read background documents or
SUMMARY:
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*
*
*
Signature. After due inquiry and to
the best of my knowledge and belief, I
certify that the information set forth in
this statement is true, complete and
correct.
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Presumption of denial ......
[FR Doc. 2023–06701 Filed 3–29–23; 8:45 am]
17 CFR Part 240
*
*
For all items subject to
the EAR. (See § 744.11
of the EAR)
on behalf of a person by an authorized
representative (other than an executive
officer of a corporation or general
partner of a partnership), evidence of
the representative’s authority to sign on
behalf of the person must be filed with
the statement. The name and any title of
each person who signs the statement
must be typed or printed beneath the
signature. See § 240.12b–11 with respect
to signature requirements.
*
Thea D. Rozman Kendler,
Assistant Secretary for Export
Administration.
Federal Register citation
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*
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,
Constance.Soves@fda.hhs.gov.
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
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Federal Register / Vol. 88, No. 61 / Thursday, March 30, 2023 / Rules and Regulations
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.
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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.
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II. Table of Abbreviations/Commonly
Used Acronyms in This Document
TABLE 1—ABBREVIATIONS AND
ACRONYMS
Abbreviation
or acronym
What it means
510(k) ...........
FDA ..............
Premarket Notification.
Food and Drug Administration.
Federal Food, Drug, and Cosmetic Act.
Premarket Approval Application.
FD&C Act .....
PMA .............
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
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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 § 888.3085 (21 CFR
888.3085) to 21 CFR 888.3083, because
a De Novo was previously granted under
§ 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.
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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.
18989
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
Units
Category
Primary
estimate
Low
estimate
High
estimate
Benefits:
Annualized Monetized $millions/year ........................................
..................
..................
Annualized Quantified ...............................................................
..................
Qualitative .................................................................................
Costs:
Annualized Monetized $millions/year ........................................
Annualized Quantified ...............................................................
Qualitative .................................................................................
Transfers:
Federal Annualized Monetized $millions/year ..........................
Year
dollars
Discount
rate
(%)
Period
covered
(years)
..................
..................
..................
..................
..................
..................
..................
..................
..................
7
3
7
3
..................
10
10
10
10
..................
$0.0008
0.0006
..................
$0.00003
0.00002
..................
$0.002
0.001
..................
2021
2021
..................
..................
..................
..................
..................
7
3
7
3
..................
10
10
10
10
10
..................
..................
..................
..................
7
3
10
10
7
3
10
10
From/To .....................................................................................
From:
Other Annualized Monetized $millions/year ..............................
..................
From/To .....................................................................................
From:
Notes
To:
..................
..................
..................
To:
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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
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-impactanalyses-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
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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.
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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
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Federal Register / Vol. 88, No. 61 / Thursday, March 30, 2023 / Rules and Regulations
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-fdaregulations.
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
1. The authority citation for part 888
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 888.3083 to subpart D to read
as follows:
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■
§ 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
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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
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,
HHS.
ACTION:
Final amendment; final order.
The Food and Drug
Administration (FDA or Agency) is
issuing a final order to require the filing
of a premarket approval application
(PMA) for spinal spheres for use in
intervertebral fusion procedures, an
unclassified, preamendments device
following the classification of the device
into class III.
DATES: This order is effective on May 1,
2023. 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 IX for the effective date of the
final order. See section VI of this
document for more information about
submitting a PMA.
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,
Constance.Soves@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background—Regulatory Authorities
The Federal Food, Drug, and Cosmetic
Act (FD&C Act), as amended, establishes
a comprehensive system for the
regulation of medical devices intended
for human use. Section 513 of the FD&C
Act (21 U.S.C. 360c) established three
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categories (classes) of devices, reflecting
the regulatory controls needed to
provide reasonable assurance of their
safety and effectiveness. The three
categories of devices are class I (general
controls), class II (special controls), and
class III (premarket approval).
Under section 513(d)(1) of the FD&C
Act, devices that were in commercial
distribution before the enactment of the
Medical Device Amendments of 1976
(the 1976 amendments) (Pub. L. 94–
295), on May 28, 1976, (generally
referred to as ‘‘preamendments
devices’’), are classified after FDA has:
(1) received a recommendation from a
device classification panel (an FDA
advisory committee); (2) published the
panel’s recommendation for comment,
along with a proposed regulation
classifying the device; and (3) published
a final regulation classifying the device.
FDA has classified most
preamendments devices under these
procedures.
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 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
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
------------------------------------------------------------------------
Abbreviation or acronym What it means
------------------------------------------------------------------------
510(k).............................. Premarket Notification.
FDA................................. Food and Drug Administration.
FD&C Act............................ Federal Food, Drug, and Cosmetic
Act.
PMA................................. Premarket Approval Application.
------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
------------------------------------
Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
