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:
BioMarket Consulting, LLC (716) 201-0228
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.