510(K) Modifications

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Submission

Comments Regarding Draft Guidance on Electronic Submission Template for Medical Device 510(k) Submissions

CHPA welcomes FDA’s efforts to modernize and streamline the process for creating and submitting 510(k) premarket notifications and generally supports the approach described in the Draft Guidance. However, CHPA recommends that FDA clarify the following key points when finalizing the Draft Guidance.

Nov 23, 2021

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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Comments on Draft Guidance for Multiple Function Device Products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

FAQs About Consumer Medical Devices

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