[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)]
[Rules and Regulations]
[Pages 67154-67155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23633]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket No. FDA 2016-N-2677]
Medical Devices; Neurological Devices; Classification of the
Evoked Photon Image Capture Device
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
Evoked Photon Image Capture Device into class I (general controls). The
Agency is classifying the device into class I (general controls) in
order to provide a reasonable assurance of safety and effectiveness of
the device.
DATES: This order is effective September 30, 2016. The classification
was applicable on July 15, 2016.
[[Page 67155]]
FOR FURTHER INFORMATION CONTACT: Kristen Bowsher, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2646, Silver Spring, MD 20993-0002, 301-
796-6448, [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), 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 (21 U.S.C. 360c(f)(2)), 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), 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) 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
January 12, 2015, EPIC Research & Diagnostics, Inc. submitted a request
for classification of the EPIC ClearView\TM\ System 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 I if general controls by themselves are sufficient to
provide reasonable assurance of safety and effectiveness of the device
for its intended use. After review of the information submitted in the
de novo request, FDA determined that the device can be classified into
class I. FDA believes general controls will provide reasonable
assurance of the safety and effectiveness of the device.
Therefore, on July 15, 2016, FDA issued an order to the requestor
classifying the device into class I. FDA is codifying the
classification of the device by adding 21 CFR 882.1561.
The device is assigned the generic name evoked photon image capture
device, and it is identified as a prescription, electrically-powered
device intended for use as a non-invasive measurement tool that applies
electricity to detect electrophysiological signals emanating from the
skin, which are reported numerically and as images without clinical
interpretation. The device is not intended for diagnostic purposes.
FDA has identified the following risks to health associated
specifically with this type of device: Adverse tissue reaction,
electromagnetic incompatibility, and electromagnetic malfunction (e.g.,
shock).
Evoked photon image capture 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).
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 refers 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, 371.
0
2. Add Sec. 882.1561 to subpart B to read as follows:
Sec. 882.1561 Evoked photon image capture device.
(a) Identification. An evoked photon image capture device is a
prescription, electrically powered device intended for use as a
noninvasive measurement tool that applies electricity to detect
electrophysiological signals emanating from the skin, which are
reported numerically and as images without clinical interpretation. The
device is not intended for diagnostic purposes.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter, subject to the limitations in Sec. 882.9.
Dated: September 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23633 Filed 9-29-16; 8:45 am]
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