Device Classification

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Press Releases and Statements

For the first time, the U.S. Food and Drug Administration (FDA) has assembled a comprehensive webpage with Consumer Medical Device information

Sep 14, 2021

Press Releases and Statements

Statement on Biden Executive Order Regarding OTC Hearing Aids from Peter Borsuk, Chair of CHPA’s Consumer Medical Devices Council, and President & CEO of Lansinoh Laboratories.

Jul 14, 2021

Submission

Enclosed herein are comments on "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device: Public Meeting: Request for Comments".

Jul 12, 2013

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