[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)]
[Rules and Regulations]
[Pages 52968-52970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22786]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2018-N-3598]


Medical Devices; General and Plastic Surgery Devices; 
Classification of the Light Based Energy Source Device for Topical 
Application

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 light based energy source device for topical application 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 light based energy source device for topical 
application'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, in part by reducing regulatory burdens.

DATES: This order is effective October 19, 2018. The classification was 
applicable on October 18, 2012.

FOR FURTHER INFORMATION CONTACT: Neil Ogden, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G414, Silver Spring, MD, 20993-0002, 301-796-6397, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the light based energy source 
device for topical application 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 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 (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 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 (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 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. 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, 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 premarket approval application (PMA) 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

    For this device, FDA issued an order on June 10, 2009, finding the 
ViruLite Cold Sore Machine not substantially equivalent to a predicate 
not subject to PMA. Thus, the device remained in class III in 
accordance with section 513(f)(1) of the FD&C Act when we issued the 
order.
    On June 30, 2009, Pacer Therapeutics, Ltd. submitted a request for 
De Novo classification of the ViruLite Cold Sore Machine. FDA reviewed 
the request in

[[Page 52969]]

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. 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 October 18, 2012, FDA issued an order to the 
requester classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 878.4860. We have named 
the generic type of device light based energy source device for topical 
application, and it is identified as a device that emits light energy 
at near infrared spectrum and is applied externally to the surface of 
herpes simplex labialis lesions on or around the lips.
    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--Light Based Energy Source Device for Topical Application Risks
                         and Mitigation Measures
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            Identified risks                   Mitigation measures
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Redness and discomfort.................  Clinical performance testing,
                                          Usability testing, and
                                          Labeling.
Burns and blisters.....................  Clinical performance testing,
                                          Usability testing, and
                                          Labeling.
Adverse tissue reaction................  Biocompatibility evaluation.
Infection/transmissibility.............  Labeling, Cleaning and
                                          disinfection validation, and
                                          Usability testing.
Electrical shock.......................  Electrical safety testing and
                                          Labeling.
Electromagnetic incompatibility........  Electromagnetic compatibility
                                          testing and Labeling.
User error.............................  Usability testing and Labeling.
Ocular injury..........................  Labeling and Non-clinical
                                          performance testing for ocular
                                          safety.
------------------------------------------------------------------------

    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. 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. This device is subject to premarket notification 
requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    We have 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. 3501-3520). 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 
quality system regulation, have been approved under OMB control number 
0910-0073; 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.

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.  878.4860 to subpart E to read as follows:


Sec.  878.4860   Light based energy source device for topical 
application.

    (a) Identification. The device emits light energy at near infrared 
spectrum and is applied externally to the surface of herpes simplex 
labialis lesions on or around the lips.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The technical parameters of the device, including wavelength, 
treatment time, treatment area, energy density, spot size, and power, 
must be characterized.
    (2) The cleaning and disinfection instructions for the device must 
be validated.
    (3) The device must be demonstrated to be biocompatible.
    (4) Performance testing must validate electromagnetic compatibility 
(EMC), ocular safety, and electrical safety of the device.
    (5) Labeling must direct end-users to contact the device 
manufacturer and MedWatch if they experience any adverse events when 
using this device.
    (6) Labeling must include specific information pertinent to use of 
the device by the intended patient population and the treatment 
regimen.
    (7) Simulated use testing must include information from a 
usability, label comprehension and self-selection study to demonstrate 
that the device can be used by the intended patient population without 
any assistance.
    (8) Clinical data must show adequate reduction in time to healing 
and assess risks of redness, discomfort, burns, and blisters.


[[Page 52970]]


    Dated: October 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22786 Filed 10-18-18; 8:45 am]
 BILLING CODE 4164-01-P


