Document ID: FDA-2021-N-1011-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; General and Plastic Surgery Devices; Classification of the Autofluorescence Detection Device for General Surgery and Dermatological Use
Posted Date: 2022-04-25T04:00Z

[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 [www.gpo.gov]
[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, [email protected].

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