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# Cranial Motion Measurement Devices Require 510(k): Correction
- URL: https://www.fdaweb.com/cranial-motion-measurement-devices-require-510-k-correction/
- Published: 2017-10-12T12:00:00.000Z
- Updated: 2026-09-14T22:55:44.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139847

*Federal Register* notice: FDA is correcting a final order entitled “Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement Device” that appeared in the 7/28 *Federal Register*. The correction notes that 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. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-10-12/pdf/2017-21982.pdf?ref=fdaweb.com).