Pharmaceutical Development Group
Pharmaceutical Consultant and FDA Regulatory Strategist
Medical Device Consultant on 510(k) SubmissionsPharmaceutical Development Group
As a medical device consultant, PDG® takes great interest in the ever-changing landscape of the premarket notification (510(k) review and clearance process.
Besides the significant scrutiny given to the program over the past five years, the vast majority of legally marketed medical devices in use in the US today were cleared via the 510(k) regulatory pathway.
The statutory mechanism giving birth to the 510(k) (as well as the IDE and PMA) was the Medical Device Amendments to the Federal Food, Drug, and Cosmetic (FD&C) Act, enacted on 28 May 1976.
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