[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Rules and Regulations]
[Pages 44771-44773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16351]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2016-N-1653]


Medical Devices; Neurological Devices; Classification of the 
Thermal System for Insomnia

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
thermal system for insomnia 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 thermal system 
for insomnia'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 July 11, 2016. The classification was 
applicable on May 13, 2016.

FOR FURTHER INFORMATION CONTACT: Leigh Anderson, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2656, Silver Spring, MD 20993-0002, 301-796-5613, 
[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). 
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.

[[Page 44772]]

    In response to a request to classify a device under either 
procedure provided by section 513(f)(2) of the FD&C Act, FDA shall 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    On October 17, 2014, Cer[ecirc]ve Inc. submitted a request for 
classification of the Cer[ecirc]ve Sleep System 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 May 13, 2016, 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 882.5700.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for a thermal 
system for insomnia will need to comply with the special controls named 
in this final order.
    The device is assigned the generic name thermal system for 
insomnia, and it is identified as a prescription device for use in 
patients with insomnia that is used to apply a specified temperature to 
the skin surface.
    FDA has identified the following risks to health associated 
specifically with this type of device, as well as the mitigation 
measures required to mitigate these risks in table 1:

   Table 1--Thermal System for Insomnia Risks and Mitigation Measures
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            Identified risk                     Mitigation method
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Adverse skin reaction..................  Biocompatibility Assessment.
                                         Labeling.
Electromagnetic Interference with Other  Electromagnetic Compatibility
 Devices.                                 Testing.
                                         Labeling.
Electrical Safety (e.g., shock)........  Electrical Safety Testing.
                                         Labeling.
Thermal Injury.........................  Non-clinical Performance
                                          Testing.
                                         Software Verification,
                                          Validation, and Hazard
                                          Analysis.
                                         Labeling.
------------------------------------------------------------------------

    FDA believes that the special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of the safety and effectiveness.
    Thermal systems for insomnia devices are not safe to use except 
under the supervision of a practitioner licensed by law to direct the 
use of the device. As such, the device is a prescription device and 
must satisfy prescription labeling requirements (see 21 CFR 801.109 
Prescription devices).
    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 thermal system for insomnia 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. DEN140032 De novo Request per 513(f)(2) from Cer[ecirc]ve, Inc., 
dated October 17, 2014.

List of Subjects in 21 CFR Part 882

    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 
882 is amended as follows:

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for part 882 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.


0
2. Add Sec.  882.5700 to subpart F to read as follows:


Sec.  882.5700  Thermal system for insomnia.

    (a) Identification. A thermal system for insomnia is a prescription 
device for use in patients with insomnia that is

[[Page 44773]]

used to apply a specified temperature to the skin surface.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (2) Performance testing must demonstrate electromagnetic 
compatibility and electrical safety.
    (3) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be evaluated:
    (i) Thermal performance of the device, including maintenance of the 
target temperature, must be evaluated under simulated use conditions.
    (ii) Mechanical testing to demonstrate the device can withstand 
forces under anticipated use conditions.
    (iii) Mechanical testing to demonstrate the device is resistant to 
leakage under anticipated use conditions.
    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) Patient labeling must be provided to convey information 
regarding safe use of the device, including instructions for assembly.

    Dated: July 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16351 Filed 7-8-16; 8:45 am]
 BILLING CODE 4164-01-P