[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 [www.gpo.gov]
[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, [email protected].

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;
 Device migration                Animal performance testing; and
 Device malposition              Labeling.
 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


