510(K) Modifications

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Press Releases and Statements

New FDA Webpage Brings OTC Medical Device Regulatory Information Into Focus

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

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Submission

Comments on Draft Guidance for Multiple Function Device Products

Jun 26, 2018

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Submission

Comments to FDA: 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device

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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FAQs About Consumer Medical Devices

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