Rule2023-00012
Medical Devices; Orthopedic Devices; Classification of the Resorbable Shoulder Spacer
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 6, 2023
Effective
January 6, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the resorbable shoulder spacer into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the resorbable shoulder spacer's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Full Text
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<title>Federal Register, Volume 88 Issue 4 (Friday, January 6, 2023)</title>
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[Federal Register Volume 88, Number 4 (Friday, January 6, 2023)]
[Rules and Regulations]
[Pages 979-981]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-00012]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. FDA-2022-N-3190]
Medical Devices; Orthopedic Devices; Classification of the
Resorbable Shoulder Spacer
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the resorbable shoulder spacer into class II (special
controls). The special controls that apply to the device type are
identified in this order and will be part of the codified language for
the resorbable shoulder spacer's classification. We are taking this
action because we have determined that classifying the device into
class II (special controls) will provide a reasonable assurance of
safety and effectiveness of the device. We believe this action will
also enhance patients' access to beneficial innovative devices.
DATES: This order is effective January 6, 2023. The classification was
applicable on July 12, 2021.
FOR FURTHER INFORMATION CONTACT: Farzana Sharmin, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4564, Silver Spring, MD 20993-0002, 301-
796-4067, <a href="/cdn-cgi/l/email-protection#5315322129323d327d003b32213e3a3d133537327d3b3b207d343c25"><span class="__cf_email__" data-cfemail="6a2c0b18100b040b4439020b180703042a0c0e0b44020219440d051c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the resorbable shoulder spacer as
class II (special controls), which we have determined will provide a
reasonable assurance of safety and effectiveness. In addition, we
believe this action will enhance patients' access to beneficial
innovation, in part by placing the device into a lower device class
than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device
that does not require premarket approval. We determine whether a new
device is substantially equivalent to a predicate device by means of
the procedures for premarket notification under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying
[[Page 980]]
the device into class III under section 513(f)(1) of the FD&C Act, the
person then requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C
Act). As a result, other device sponsors do not have to submit a De
Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less-burdensome 510(k) process, when necessary, to market their device.
II. De Novo Classification
On June 12, 2020, FDA received Ortho-Space, Ltd.'s request for De
Novo classification of the InSpace Subacromial Tissue Spacer System.
FDA reviewed the request in order to classify the device under the
criteria for classification set forth in section 513(a)(1) of the FD&C
Act.
We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
Therefore, on July 12, 2021, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
888.3630.\1\ We have named the generic type of device resorbable
shoulder spacer, and it is identified as a device intended to act as a
temporary spacer, creating a physical barrier between tissues in the
shoulder, for the treatment of massive irreparable rotator cuff tears.
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\1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) 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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FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.
Table 1--Resorbable Shoulder Spacer Risks and Mitigation Measures
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Identified risks Mitigation measures
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No improvement in shoulder function and Clinical performance testing;
pain reduction due to device failure Non-clinical performance
from: testing;
<bullet> Device migration Animal performance testing; and
<bullet> Device malposition Labeling.
<bullet> Device collapse
Increased risk of adverse events of the Clinical performance testing;
index shoulder (e.g., pain, spasm, and and
swelling, subsequent medical and Labeling.
surgical treatments secondary to
disease progression).
Adverse tissue reaction................ Biocompatibility evaluation;
Animal performance testing;
Non-clinical performance
testing; and
Labeling.
Infection.............................. Sterilization validation;
Pyrogenicity testing;
Shelf life testing; and
Labeling.
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FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. We encourage sponsors to consult with us if they wish to
use a non-animal testing method they believe is suitable, adequate,
validated, and feasible. We will consider if such an alternative method
could be assessed for equivalency to an animal test method. This device
is subject to premarket notification requirements under section 510(k)
of the FD&C Act.
III. Analysis of Environmental Impact
The Agency has 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.
IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The
[[Page 981]]
collections of information in 21 CFR part 860, subpart D, regarding De
Novo classification have been approved under OMB control number 0910-
0844; the collections of information in part 814, subparts A through E,
regarding premarket approval, have been approved under OMB control
number 0910-0231; the collections of information in part 807, subpart
E, regarding premarket notification submissions, have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR part 820, regarding quality system regulation, have been
approved under OMB control number 0910-0073; and the collections of
information in 21 CFR part 801, regarding labeling, have been approved
under OMB control number 0910-0485.
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. 888.3630 to subpart D to read as follows:
Sec. 888.3630 Resorbable shoulder spacer.
(a) Identification. A resorbable shoulder spacer is intended to act
as a temporary spacer, creating a physical barrier between tissues in
the shoulder, for the treatment of massive irreparable rotator cuff
tears.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical performance testing must demonstrate that the device
performs as intended under anticipated conditions of use and include
the following:
(i) Evaluation of improvement of shoulder function and reduction of
symptoms (e.g., pain and function) for the indications for use; and
(ii) Evaluation of relevant adverse events.
(2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use and
include the following:
(i) Integrity testing of the device, including mechanical and
chemical stability; and
(ii) Characterization of the device degradation profile.
(3) Animal performance testing must include evaluation of the
following:
(i) Adverse effects, including gross necropsy and histopathology;
and
(ii) Device degradation to verify in vitro versus in vivo
degradation correlation.
(4) All patient-contacting components of the device must be
demonstrated to be biocompatible.
(5) Performance data must support the sterility and pyrogenicity of
the device components intended to be sterile.
(6) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the identified shelf life.
(7) Labeling must include the following:
(i) Instruction for use, including specific instructions regarding
device selection and placement;
(ii) A detailed summary of the clinical performance testing with
the device, including procedure- and device-related complications or
adverse events; and
(iii) A shelf life.
Dated: January 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00012 Filed 1-5-23; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on January 6, 2023.
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