[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)]
[Rules and Regulations]
[Pages 52966-52968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22837]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2018-N-3696]


Medical Devices; General and Plastic Surgery Devices; 
Classification of the Wound Autofluorescence Imaging Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the wound autofluorescence imaging device into class I. We are taking 
this action because we have determined that classifying the device into 
class I 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, in part by reducing regulatory 
burdens.

DATES: This order is effective October 19, 2018. The classification was 
applicable on July 31, 2018.

FOR FURTHER INFORMATION CONTACT: Yasaman Ardeshirpour, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. G455, Silver Spring, MD, 20993-0002, 
240-402-3706, [email protected].

SUPPLEMENTARY INFORMATION: 

[[Page 52967]]

I. Background

    Upon request, FDA has classified the wound autofluorescence imaging 
device as class I (general 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 reducing regulatory burdens 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 to a predicate device that does not require 
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new 
device is substantially equivalent to a predicate 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 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 shall 
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 (21 U.S.C. 360c(a)(1)). Although the device 
was automatically 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, in part by reducing regulatory 
burdens. 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 21 U.S.C. 360c(f)(2)(B)(i)). As a 
result, other device sponsors do not have to submit a De Novo request 
or PMA 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 February 16, 2018, MolecuLight, Inc. submitted a request for De 
Novo classification of the MolecuLight i:X. 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 I if general controls are sufficient 
to provide reasonable assurance of the safety and effectiveness of the 
device for its intended use (see 21 U.S.C. 360c(a)(1)(A)). After review 
of the information submitted in the request, we determined that the 
device can be classified into class I. FDA has determined that general 
controls will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on July 31, 2018, FDA issued an order to the requester 
classifying the device into class I. FDA is codifying the 
classification of the device by adding 21 CFR 878.4165. We have named 
the generic type of device wound autofluorescence imaging device, and 
it is identified as a tool to view autofluorescence images from skin 
wounds that are exposed to an excitation light. The device is not 
intended to provide quantitative or diagnostic information.
    FDA has identified the following risks to health associated 
specifically with this type of device: electrical/mechanical/thermal, 
electromagnetic compatibility (EMC) and optical safety of the device, 
and the error in fluorescence detection from the wound.
    Section 510(l)(1) of the FD&C Act provides that a device within a 
type that has been classified into class I under section 513 of the 
FD&C Act is exempt from premarket notification under section 510(k), 
unless the device is of substantial importance in preventing impairment 
of human health or presents a potentially unreasonable risk of illness 
or injury (21 U.S.C. 360(l)(1)). Devices within this type are exempt 
from the premarket notification requirements under section 510(k), 
subject to the limitations of exemptions in 21 CFR 878.9.

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 refers 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. 3501-3520). 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 21 CFR part 
820, regarding current good manufacturing practices, have been approved 
under OMB control number 0910-0073; and the collections of information 
in part 807, subpart E, regarding premarket notification submissions, 
have been approved under OMB control number 0910-0120; and the 
collections of information in 21 CFR part 801, regarding labeling, have 
been approved under OMB control number 0910-0485.

[[Page 52968]]

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, 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.  878.4165 to subpart E to read as follows:


Sec.  878.4165  Wound autofluorescence imaging device.

    (a) Identification. A wound autofluorescence imaging device is a 
tool to view autofluorescence images from skin wounds that are exposed 
to an excitation light. The device is not intended to provide 
quantitative or diagnostic information.
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec.  878.9.

    Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22837 Filed 10-18-18; 8:45 am]
 BILLING CODE 4164-01-P


