[Federal Register Volume 81, Number 125 (Wednesday, June 29, 2016)]
[Rules and Regulations]
[Pages 42243-42245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15381]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2016-N-1618]


Medical Devices; General and Plastic Surgery Devices; 
Classification of the Electrosurgical Device for Over-the-Counter 
Aesthetic Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is classifying the 
electrosurgical device for over-the-counter aesthetic use into class II 
(special controls). The special controls that will apply to the device 
are identified in this order and will be part of the codified language 
for the electrosurgical device for over-the-counter aesthetic use's 
classification. The Agency is classifying the device into class II 
(special controls) in order to provide a reasonable assurance of safety 
and effectiveness of the device.

DATES: This order is effective June 29, 2016. The classification was 
applicable on December 18, 2015.

FOR FURTHER INFORMATION CONTACT: Long Chen, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G472, Silver Spring, MD 20993-0002, 301-796-6389, 
Long.Chen@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were 
not in commercial distribution before May 28, 1976 (the date of 
enactment of the Medical Device Amendments of 1976), generally referred 
to as postamendments devices, are classified automatically by statute 
into class III without any FDA rulemaking process. These devices remain 
in class III and require premarket approval, unless and until the 
device is classified or reclassified into class I or II, or FDA issues 
an order finding the device to be substantially equivalent, in 
accordance with section 513(i) of the FD&C Act, to a predicate device 
that does not require premarket approval. The Agency determines whether 
new devices are substantially equivalent to predicate devices by means 
of premarket notification procedures in section 510(k) of the FD&C Act 
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act as amended by section 607 of the 
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to 
classify a device under the criteria set forth in section 513(a)(1) of 
the FD&C Act. Under the first procedure, the person submits a premarket 
notification under section 510(k) of the FD&C Act for a device that has 
not previously been classified and, within 30 days of receiving an 
order classifying the device into class III under section 513(f)(1) of 
the FD&C Act, the person requests a classification under section 
513(f)(2). Under the second procedure, rather than first submitting a 
premarket notification under section 510(k) of the FD&C Act and then a 
request for classification under the first procedure, the person 
determines that there is no legally marketed device upon which to base 
a determination of substantial equivalence and requests a 
classification under section 513(f)(2) of the FD&C Act. If the person 
submits a request to classify the device under this second procedure, 
FDA may decline to undertake the classification request if FDA 
identifies a legally marketed device that could provide a reasonable 
basis for review of substantial equivalence with the device or if FDA 
determines that the device submitted is not of ``low-moderate risk'' or 
that general controls would be inadequate to control the risks and 
special controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either 
procedure provided by section 513(f)(2) of the FD&C Act, FDA will 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    On January 13, 2015, EndyMed Medical Ltd., submitted a request for 
classification of the NewaTM device under section 513(f)(2) 
of the FD&C Act. The manufacturer recommended that the device be 
classified into class II (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, 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. FDA 
classifies 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 to provide reasonable assurance of the safety and 
effectiveness of the device for its intended use. After review of the 
information submitted in the request, FDA determined that the device 
can be classified into class II with the establishment of special 
controls. FDA believes these special controls, in addition to general 
controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on December 18, 2015, FDA issued an order to the 
requestor classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 878.4420.

[[Page 42244]]

    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for an 
electrosurgical device for over-the-counter aesthetic use will need to 
comply with the special controls named in this final order.
    The device is assigned the generic name electrosurgical device for 
over-the-counter aesthetic use, and it is identified as a device using 
radiofrequency energy to produce localized heating within tissues for 
non-invasive aesthetic use.
    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--Electrosurgical Device for Over-the-Counter Aesthetic Use Risks
                         and Mitigation Measures
------------------------------------------------------------------------
            Identified risk                     Mitigation measure
------------------------------------------------------------------------
Infection..............................  Cleaning Validation.
                                         Labeling.
Adverse Tissue Reaction................  Biocompatibility.
Skin Overheating/Burn..................  Clinical Performance Testing.
                                         Non-clinical Performance
                                          Testing.
                                         Software Verification,
                                          Validation and Hazards
                                          Analysis.
                                         Labeling.
Electromagnetic Interference/Electrical  Electromagnetic Compatibility
 Shock.                                   Testing.
                                         Electrical Safety Testing.
                                         Labeling.
Worsening Aesthetic Outcomes...........  Clinical Performance Testing.
Use Error..............................  Usability Study.
                                         Labeling.
Failure to Identify Correct Population   Label Comprehension and Self-
 and Condition.                           Selection Study.
                                         Labeling.
------------------------------------------------------------------------

    FDA believes that the special controls, in addition to the general 
controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k) of the FD&C Act, if FDA determines that premarket notification 
is not necessary to provide reasonable assurance of the safety and 
effectiveness of the device. For this type of device, FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of the safety and effectiveness of the device. 
Therefore, this device type is not exempt from premarket notification 
requirements. Persons who intend to market this type of device must 
submit to FDA a premarket notification, prior to marketing the device, 
which contains information about the electrosurgical device for over-
the-counter aesthetic use they intend to market.

II. 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.

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations. 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 
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.

IV. Reference

    The following reference is on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, and is available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; it 
is also available electronically at http://www.regulations.gov.

    1. DEN150005: De Novo Request per 513(f)(2) from EndyMed Medical 
Ltd., dated January 13, 2015.

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.  878.4420 to subpart E to read as follows:


Sec.  878.4420  Electrosurgical device for over-the-counter aesthetic 
use.

    (a) Identification. An electrosurgical device for over-the-counter 
aesthetic use is a device using radiofrequency energy to produce 
localized heating within tissues for non-invasive aesthetic use.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance data must demonstrate that the device 
meets all design specifications and performance requirements. The 
following performance characteristics must be tested: Over-heating, 
power accuracy radiofrequency, pulse cycle, waveform, pulse duration, 
and device characterization parameters.
    (2) Label comprehension and self-selection performance evaluation 
must demonstrate that the intended over-the-counter users can 
understand the package labeling and correctly choose the device for the 
indicated aesthetic use.
    (3) Usability performance evaluation must demonstrate that the 
over-the-counter user can correctly use the device, based solely on 
reading the

[[Page 42245]]

directions for use, to treat the indicated aesthetic use.
    (4) Clinical performance evaluation must demonstrate that the 
device performs as intended under anticipated conditions of use to 
achieve the intended aesthetic results.
    (5) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (6) Instructions for cleaning the device must be validated.
    (7) Performance data must be provided to demonstrate the 
electromagnetic compatibility and electrical safety, including the 
mechanical integrity, of the device.
    (8) Software verification, validation, and hazard analysis must be 
performed.
    (9) Labeling must include:
    (i) Warnings, precautions, and contraindications to ensure the safe 
use of the device for the over-the-counter users.
    (ii) A statement that the safety and effectiveness of the device's 
use for uses other than the indicated aesthetic use are not known.
    (iii) A summary of the clinical information used to establish 
effectiveness for each indicated aesthetic usage and observed adverse 
events.

    Dated: June 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-15381 Filed 6-28-16; 8:45 am]
 BILLING CODE 4164-01-P