Issuance of Draft Guidance for Tinnitus Marker Devices

The FDA recently released a draft guidance for the regulation of Tinnitus Marker Devices. These devices are regulated as Class II devices. The guidance covers topics including the content and format of the 510(k) application, scope, device description, risks to health, preclinical and clinical testing and labeling.

For the complete guidance, please refer to the following document:

http://www.fda.gov/cdrh/ode/guidance/1555.pdf

If you have any questions regarding this report, please email us at

info@mdiconsultants.com

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