Document ID: FDA-2017-N-1608-0002
Agency: fda
Document Type: Rule
Title: Medical Devices: Neurological Devices; Classification of Cranial Motion Measurement Device; Correction
Posted Date: 2017-10-12T04:00Z

[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Rules and Regulations]
[Page 47373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21982]

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

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; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order; correction.

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

SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
order entitled ``Medical Devices; Neurological Devices; Classification 
of Cranial Motion Measurement Device'' that appeared in the Federal 
Register of July 28, 2017. The final order was published with an 
incorrect statement in the preamble about whether FDA planned to exempt 
the device from premarket notification requirements. This document 
corrects that error.

DATES: Effective October 12, 2017.

FOR FURTHER INFORMATION CONTACT: Jay Gupta, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2611, Silver Spring, MD 20993-0002, 301-796-2795, 
jay.gupta@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 28, 2017 (82 
FR 35069), FDA published the final order ``Medical Devices; 
Neurological Devices; Classification of Cranial Motion Measurement 
Device.'' The final order published with an incorrect statement in the 
preamble about whether FDA planned to exempt the device from premarket 
notification requirements under section 510(k) of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)).

Correction

    In the Federal Register of July 28, 2017, in FR Doc. 2017-15895, 
the following correction is made:

    On page 35070, after table 1 in the third column, the last 
paragraph is corrected to read as follows:
    ``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 
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 cranial 
motion measurement device they intend to market.''

    Dated: October 4, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-21982 Filed 10-11-17; 8:45 am]
 BILLING CODE 4164-01-P