FDA Issues Draft Guidance on 510(k) Electronic Submission Template

The U.S. Food and Drug Administration (FDA) has issued a draft guidance to further support its efforts to facilitate the online submission of 510(k) review requests.

The draft guidance, “Electronic Submission Template for Medical Device 510(k) Submissions,” is intended to provide medical device manufacturers with up-to-date resources and information to support 510(k) submissions to the FDA. The effort is the first of several individual guidances that the agency is expected to issue to facilitate the full range of medical device filings with the FDA, and is part of the agency’s overall effort to improve submission consistency and enhance the efficiency of the agency’s review process.

Guidances issued by the FDA and other federal agencies are intended only to provide insight in the agency’s views on a particular issue and do not have the force of law.

Read the draft guidance as published in the Federal Register is available. 

Comments on the proposed draft guidance can be submitted through www.regulations.gov until November 28, 2021 (be sure to reference Docket ID FDA-2021-D-0872).

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