[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Rules and Regulations]
[Pages 35069-35071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15895]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2017-N-1608]


Medical Devices; Neurological Devices; Classification of Cranial 
Motion Measurement Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is 
classifying the cranial motion measurement device 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 cranial motion measurement device'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 28, 2017. The classification was 
applicable on August 1, 2016.

FOR FURTHER INFORMATION CONTACT: Jay Gupta, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2630, Silver Spring, MD 20993-0002, 301-796-2795, 
jay.gupta@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

[[Page 35070]]

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, also known as De Novo 
classification, 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), the 
person requests a classification under section 513(f)(2) of the FD&C 
Act. 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 shall 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    On December 23, 2014, Jan Medical, Inc., submitted a request for 
classification of the BrainPulse, Model 1100, under section 513(f)(2) 
of the FD&C Act.
    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). 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 August 1, 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 882.1630.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for a cranial 
motion measurement device will need to comply with the special controls 
named in this final order. A De Novo classification decreases 
regulatory burdens. When FDA classifies a device type as class I or II 
via the De Novo pathway, other manufacturers do not have to submit a De 
Novo request or premarket approval application in order to market the 
same type of device, unless the device has a new intended use or 
technological characteristics that raise different questions of safety 
or effectiveness. Instead, manufacturers can use the less burdensome 
510(k) pathway, when necessary, to market their device, and the device 
that was the subject of the original De Novo classification can serve 
as a predicate device for additional 510(k)s from other manufacturers.
    The device is assigned the generic name cranial motion measurement 
device, and it is identified as a prescription device that utilizes 
accelerometers to measure the motion or acceleration of the skull. 
These measurements are not to be used for diagnostic purposes.
    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--Cranial Motion Measurement Device Risks to Health and
                           Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction................  Biocompatibility evaluation.
                                         Labeling.
Equipment malfunction leading to injury  Electrical safety, thermal, and
 to user or patient.                      mechanical testing.
                                         Electromagnetic compatibility
                                          testing.
                                         Labeling.
Inaccurate measurement.................  Clinical performance testing.
                                         Hardware and software
                                          verification, validation, and
                                          hazard analysis.
                                         Electromagnetic compatibility
                                          testing.
                                         Labeling.
Use error..............................  Hardware and 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 safety and effectiveness.
    Cranial motion measurement devices are not safe for 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), if FDA determines that premarket notification is not necessary 
to provide reasonable assurance of the safety and

[[Page 35071]]

effectiveness of the device. For this type of device, FDA believes 
premarket notification is not necessary to provide reasonable assurance 
of the safety and effectiveness of the device type and, therefore, is 
planning to exempt the device from the premarket notification 
requirements under section 510(m) of the FD&C Act. Once finalized, 
persons who intend to market this device type need not submit a 510(k) 
premarket notification containing information on the cranial motion 
measurement device prior to marketing.

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.

List of Subjects in 21 CFR Part 882

    Medical devices; Neurological 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, 360l, 371.


0
2. Add Sec.  882.1630 to subpart B to read as follows:


Sec.  882.1630  Cranial motion measurement device.

    (a) Identification. A cranial motion measurement device is a 
prescription device that utilizes accelerometers to measure the motion 
or acceleration of the skull. These measurements are not to be used for 
diagnostic purposes.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The technical parameters of the device, hardware and software, 
must be fully characterized and include the following information:
    (i) Hardware specifications must be provided. Additionally, 
verification and validation testing as well as a hazard analysis must 
be performed.
    (ii) Software must be described in detail in the Software 
Requirements Specification (SRS) and Software Design Specification 
(SDS). Additionally, software verification and validation testing as 
well as a hazard analysis must be performed.
    (2) The device parts that contact the patient must be demonstrated 
to be biocompatible.
    (3) The device must be designed and tested for electrical, thermal, 
and mechanical safety, and electromagnetic compatibility (EMC).
    (4) Clinical performance testing must demonstrate the accuracy, 
precision, stability, and repeatability of measuring cranial motion per 
the intended use in the intended use environment.
    (5) The labeling must include:
    (i) The intended use population and the intended use environment.
    (ii) Instructions for technicians to convey to patients regarding 
the collection of cranial acceleration data to ensure device 
measurement accuracy, precision, stability, and repeatability.
    (iii) Information allowing clinicians to understand potential 
sources of variability in the measurement to help recognize and 
identify changes in the measurement.

    Dated: July 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-15895 Filed 7-27-17; 8:45 am]
BILLING CODE 4164-01-P