[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]
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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.
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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,
[email protected].
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
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Identified risk Mitigation measure
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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.
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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