Friday, January 2, 2009

FDA 510(k) Free Tips And Pearls Of Wisdom

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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1 comment:

Bhuvan Chand said...

great article................keep writing. If you want information about any diseases click here

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