[Federal Register Volume 87, Number 249 (Thursday, December 29, 2022)]
[Rules and Regulations]
[Pages 80040-80042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-28166]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. FDA-2022-N-3144]


Medical Devices; Orthopedic Devices; Classification of the 
Resorbable Implant for Anterior Cruciate Ligament (ACL) Repair

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
classifying the resorbable implant for anterior cruciate ligament (ACL) 
repair 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 implant for ACL repair'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 December 29, 2022. The classification 
was applicable on December 16, 2020.

FOR FURTHER INFORMATION CONTACT: Pooja Panigrahi, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 4572, Silver Spring, MD 20993-0002, 240-
402-1090, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the resorbable implant for ACL 
injuries 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 (21 U.S.C. 360c(f)(2)). 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 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 in order to market a 
substantially equivalent device (see 21 U.S.C. 360c(i), 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 4, 2020, FDA received Miach Orthopaedics, Inc.'s request 
for De Novo classification of the BEAR[supreg] (Bridge-Enhanced ACL 
Repair) Implant. 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.

[[Page 80041]]

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 December 16, 2020, 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 
888.3044.\1\ We have named the generic type of device resorbable 
implant for ACL repair, and it is identified as a degradable material 
that allows for healing of a torn ACL that is biomechanically 
stabilized by traditional suturing procedures. The device is intended 
to protect the biological healing process from the surrounding 
intraarticular environment and not intended to replace biomechanical 
fixation via suturing. This classification includes devices that bridge 
or surround the torn ends of a ruptured ACL.
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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 Implant for Anterior Cruciate Ligament (ACL) Repair
                      Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Repaired ACL has inadequate durability,  Animal testing, Clinical
 leading to re-tear.                      performance testing, and
                                          Labeling.
Repaired ACL is loose or functionally    Clinical performance testing.
 limited, leading to joint instability.
ACL does not heal due to inadequate      Non-clinical performance
 resorption or migration of implant.      testing and Animal testing.
Adverse tissue reaction................  Biocompatibility evaluation and
                                          Labeling.
Infection..............................  Sterilization validation, Shelf-
                                          life testing, and Labeling.
Febrile response due to endotoxins.....  Pyrogenicity testing.
Implant is incompatible with other ACL   Non-clinical performance
 repair instrumentation and sutures,      testing and Labeling.
 leading to inability to complete
 surgery.
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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. In order 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 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 21 CFR 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.  888.3044 to subpart D to read as follows:


Sec.  888.3044  Resorbable implant for anterior cruciate ligament (ACL) 
repair.

    (a) Identification. A resorbable implant for anterior cruciate 
ligament (ACL) repair is a degradable material that allows for healing 
of a torn ACL that is biomechanically stabilized by traditional 
suturing procedures. The device is intended to protect the biological 
healing process from the surrounding intraarticular environment and not 
intended to replace biomechanical fixation via suturing. This 
classification includes devices that bridge or surround the torn ends 
of a ruptured ACL.
    (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) Post-operative evaluation of knee pain and function; and
    (ii) Durability as assessed by re-tear or re-operation rate.
    (2) Animal performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use and include 
the following:
    (i) Device performance characteristics, including resorption and 
ligament healing at repair site; and

[[Page 80042]]

    (ii) Adverse effects as assessed by gross necropsy and 
histopathology.
    (3) Non-clinical testing must demonstrate that the device performs 
as intended under anticipated conditions of use and include the 
following:
    (i) Characterization of materials, including chemical composition, 
resorption profile, and mechanical properties; and
    (ii) Simulated use testing, including device preparation, device 
handling, compatibility with other ACL repair instrumentation, and user 
interface.
    (4) The device must be demonstrated to be biocompatible.
    (5) Performance data must demonstrate the device to be sterile and 
non-pyrogenic.
    (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) Identification of device materials and specifications;
    (ii) A summary of the clinical performance testing conducted with 
the device;
    (iii) Instructions for use, including compatibility with other ACL 
repair instrumentation or devices;
    (iv) Warnings regarding post-operative rehabilitation requirements; 
and
    (v) A shelf life.

    Dated: December 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-28166 Filed 12-28-22; 8:45 am]
BILLING CODE 4164-01-P