FDA 510(k) Free Tips And Pearls Of Wisdom

Updated July 6, 2023

The original links broke.

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510(k) Clearances - FDA.gov

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If you're working on a 510(k) medical device submission, you might want to peek at this Medical Device Blog post that's full of great tips for avoiding heartaches, "510(k) Approval Timeline." There's some really good stuff there. Did you find those tips helpful? If you need more info, try the FDA's own site . . . The FDA's Information on Releasable 510(k)s: General Information Federal Register Notices Search the Releasable 510(k) Database Listing of CDRH Substantially Equivalent (SE) 510(k) Summaries or 510(k) Statements, for Final Decisions Rendered Downloadable 510(k) Files One gem is the FDA's "SCREENING CHECKLIST - ALL PREMARKET NOTIFICATION [510(k)] SUBMISSIONS" (free) that's used to assess whether your paperwork is complete enough or not for a substantive review. 

Previous 510(k) Posts: Medical Devices - A murky 510(k) world?! Medical Devices Containing Antimicrobial Agents - FDA Guidance Pending 

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