Rule2022-08731
Medical Devices; General and Plastic Surgery Devices; Classification of the Autofluorescence Detection Device for General Surgery and Dermatological Use
Primary source
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Published
April 25, 2022
Effective
April 25, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is classifying the autofluorescence detection device for general surgery and dermatological use 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 autofluorescence detection device for general surgery and dermatological use'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 79 (Monday, April 25, 2022)</title>
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[Federal Register Volume 87, Number 79 (Monday, April 25, 2022)]
[Rules and Regulations]
[Pages 24271-24273]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08731]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA-2021-N-1011]
Medical Devices; General and Plastic Surgery Devices;
Classification of the Autofluorescence Detection Device for General
Surgery and Dermatological Use
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the autofluorescence detection device for general surgery and
dermatological use 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 autofluorescence
detection device for general surgery and dermatological use'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 April 25, 2022. The classification was
applicable on November 2, 2018.
FOR FURTHER INFORMATION CONTACT: Jessica Mavadia-Shukla, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 4643, Silver Spring, MD 20993-0002,
301-348-1596, <a href="/cdn-cgi/l/email-protection#90daf5e3e3f9f3f1beddf1e6f1f4f9f1bdc3f8e5fbfcf1d0f6f4f1bef8f8e3bef7ffe6"><span class="__cf_email__" data-cfemail="92d8f7e1e1fbf1f3bcdff3e4f3f6fbf3bfc1fae7f9fef3d2f4f6f3bcfafae1bcf5fde4">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the autofluorescence detection
device for general surgery and dermatological use 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, 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
[[Page 24272]]
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 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). 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.
We believe this De Novo classification will enhance patients'
access to beneficial innovation. 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 September 27, 2017, FDA received AiBiomed, Corp.'s request for
De Novo classification of the Parathyroid Detection (Model PTeye)
System. Subsequently, on December 22, 2017, FDA received Fluoptics's
similar request for De Novo classification of the Fluobeam 800 Clinic
Imaging Device used with Fluocase 800 Control System. FDA reviewed both
requests in order to classify the devices 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 requests, we determined that the devices
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 devices.
Therefore, on November 2, 2018, FDA issued orders to both
requesters classifying the devices into class II. In this final order,
FDA is codifying the classification of these devices by adding 21 CFR
878.4550.\1\ We have named the generic type of device autofluorescence
detection device for general surgery and dermatological use, and it is
identified as an adjunct tool that uses autofluorescence to detect
tissues or structures. This device is not intended to provide a
diagnosis.
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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 Registers (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--Autofluorescence Detection Device for General Surgery and
Dermatological Use Risks and Mitigation Measures
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Identified risks Mitigation measures
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Electrical, mechanical, or thermal Electromagnetic compatibility
hazards leading to user injury or testing; Electrical, mechanical and
discomfort. thermal safety testing; Software
verification, validation, and
hazard analysis; and Labeling.
Tissue, skin burn, or eye injury Light and laser exposure safety
due to light and laser exposure. testing and Labeling.
Infection and cross contamination. Sterilization validation, Shelf life
testing, and Labeling.
Adverse tissue reaction........... Biocompatibility evaluation.
False identification of target In vivo performance testing;
tissues or structures leading to Software verification, validation,
errors in patient management and hazard analysis; and Labeling.
(e.g., removal of healthy tissue
or not removing diseased tissue).
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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.
[[Page 24273]]
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 the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' 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 878
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
878 is amended as follows:
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
0
1. The authority citation for part 878 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 878.4550 to subpart E to read as follows:
Sec. 878.4550 Autofluorescence detection device for general surgery
and dermatological use.
(a) Identification. An autofluorescence detection device for
general surgery and dermatological use is an adjunct tool that uses
autofluorescence to detect tissues or structures. This device is not
intended to provide a diagnosis.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) In vivo testing under anticipated conditions of use must
characterize the ability of the device to detect autofluorescent
signals from tissues or structures consistent with the indications for
use.
(2) The patient-contacting components of the device must be
demonstrated to be biocompatible.
(3) Performance testing must demonstrate the electromagnetic
compatibility and electrical, mechanical, and thermal safety of the
device.
(4) Software verification, validation, and hazard analysis must be
performed.
(5) Performance testing must demonstrate the sterility of patient-
contacting components of the device.
(6) Performance testing must support the shelf life of device
components provided sterile by demonstrating continued sterility and
package integrity over the labeled shelf life.
(7) Performance testing must demonstrate laser and light safety for
eye, tissue, and skin.
(8) Labeling must include the following:
(i) Instructions for use;
(ii) The detection performance characteristics of the device when
used as intended; and
(iii) A shelf life for any sterile components.
Dated: April 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08731 Filed 4-22-22; 8:45 am]
BILLING CODE 4164-01-P
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