Archive for December, 2012

December 7, 2012   Posted by: thomasetoconnor

Checklist for FDA 510(k) Submissions

Screening Checklist for Traditional/Abbreviated Premarket Notification [510(k)] Submissions based on Guidance for Industry and FDA Staff Format for Traditional and Abbreviated 510(k)s   OConnor BMC FDA checklist 18F

Successfully navigating the 510(K) submission process is essential to launching your medical device. This checklist will provide a useful road map for novices as well as those who have been through the process before.  The current state of Regulatory Affairs is subject to changes in the months ahead. If you are in need of practical advice as you are actively working to bring a device to market please do not hesitate to contact BioMarketing Consulting, LLC for help with:

  • Selecting your devices regulation number and product code
  • Selecting the predicate device
  • Finding relevant Guidance documents
  • Choosing the best 510(k) format; traditional, abbreviated, special
  • Review of recent changes to FDA regulations for medical devices
  • Review of proposed changes to FDA regulation and what we think is going to happen
  • Progress of CDRH and HHS 2010 Action Plan

 

BioMarket Consulting, LLC  (716) 201-0228

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BioMarket Consulting, LLC Our experienced advisory team will accelerate the go-to-market strategy for entrepreneurs and investors in biomedical, molecular diagnostic & life science ventures. We can reduce the time-to-market, reduce the risk and optimize the return on investment.