Rule2022-28166
Medical Devices; Orthopedic Devices; Classification of the Resorbable Implant for Anterior Cruciate Ligament (ACL) Repair
Primary source
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Published
December 29, 2022
Effective
December 29, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 249 (Thursday, December 29, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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, <a href="/cdn-cgi/l/email-protection#d181bebebbb0ff81b0bfb8b6a3b0b9b891b7b5b0ffb9b9a2ffb6bea7"><span class="__cf_email__" data-cfemail="c898a7a7a2a9e698a9a6a1afbaa9a0a188aeaca9e6a0a0bbe6afa7be">[email protected]</span></a>.
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
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