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

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Information about this document as published in the Federal Register.

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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.

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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.

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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.”

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Dated: October 4, 2017.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2017-21982 Filed 10-11-17; 8:45 am]

BILLING CODE 4164-01-P