Pharmaceutical Development Group

Pharmaceutical Consultant and FDA Regulatory Strategist

Medical Device Consultant on 510(k) Submissions

Pharmaceutical 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.[1]

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.

Download to find out more.

Available Downloads