FDA regulatory pathways for medical devices

AdobeStock_414656141_Editorial_Use_Only

The regulations, developed as a result of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1938, share a common goal with the pharmaceutical regulations: they both strive to ensure that new medical treatments reach the public as quickly as possible while protecting patients and ensuring that the new treatments have a positive benefit–risk balance. However, they approach this goal in different ways. This continuing professional development supplement explains the fundamentals of the FDA regulatory pathways for medical device manufacturers that wish to bring their products to the US market.

 This is member-only content

To read this article, SIGN IN NOW if you are a TOPRA member.

Not a TOPRA member yet? 

Join now to get access to:

  • Features and specialist articles
  • CPD supplements
  • Comprehensive archive

Not sure yet?  Read one of our free editorials to see what you’re missing out on!