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FDA Issues Final Guidance on Electronic Submission Template for Medical Device 510(k) Submissions

Today, the U.S. Food and Drug Administration (FDA) issued the final guidance: Electronic Submission Template for Medical Device 510(k) Submissions. The guidance describes resources to support electronic submission of premarket notifications [510(k)s] to the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).

This final guidance:

• Describes significant terminology associated with electronic submissions.
• Explains current electronic submission template structure, format, and use.
• Explains electronic submission template waivers, exemptions, and timing.

This final guidance represents one of several steps in meeting the FDA's commitment to develop electronic submission templates that can serve as preparation tools for industry to improve submission consistency and enhance efficiency in the FDA’s review process. The FDA has identified October 1, 2023, as that date on which 510(k) electronic submission requirements will take effect.

Questions?

If you have questions about this final guidance, contact the Division of Industry and Consumer Education.