Device Classification

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FDA issued a long-awaited proposed rule which has the potential to positively affect the lives of millions of consumers by increasing access to affordable over-the-counter (OTC) hearing aids and personal sound amplification products for those who experience hearing loss.

Oct 19, 2021

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

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

Here are the Federal Register notice summary excerpts that might be of interest to you or others within your organization. Please see notices for complete details.

Jul 7, 2021

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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