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New FDA Guidance Provides Standards for Medical Device 510(k) Submissions

The U.S. Food and Drug Administration (FDA) issued a new guidance, entitled Electronic Submission Template for Medical Device 510(k) Submissions. 510(k) electronic submission requirements will take effect on October 1, 2023. This guidance document introduces the resources publicly available to support electronic 510(k) submissions to FDA.

Who is this guidance intended for?

This guidance provides information for industry and FDA Staff.

What issues does the guidance address?

The technical standards described, establish the 510(k) electronic format for complying with section 745(A)(b)(3) of the FD&C Act. Specifically, the guidance reviews:

  • Structure of the current 510(k) Electronic Submission Template
  • Waivers and Exemptions From Electronic Submission Requirements
  • When Electronic Submissions Will Be Required

View the guidance page to download the final guidance document and for information on how to submit a formal comment.


 

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Electronic Submission Template for Medical Device 510(k) Submissions View Final Guidance Page