FDA Guidance Documents
The FDA has released several draft guidance documents aimed at modernizing the 510K process. These documents are presently in draft form, and the agency is is welcoming reviewer feedback until December 6, 2023. If you have a vested interest in or currently utilize these documents, I recommend reviewing them and sharing your comments.
For reference, the relevant documents are listed below.
- Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission: Draft Guidance for Industry and Food and Drug Administration Staff (fda.gov)
- Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration Staff (fda.gov)
- Evidentiary Expectations for 510(k) Implant Devices: Draft Guidance for Industry and Food and Drug Administration Staff (fda.gov)
- Instructions for Submitting Drafts of Proposed Guidance Documents Electronically | FDA