Alerts1.8.20

FDA Final Order Exempts Certain Medical Devices From Premarket Notification

medical device 4

At the end of 2019, the Food and Drug Administration (FDA) published a final order and a final amendment exempting several categories of medical devices from the premarket notification requirements of Section 510(k) of the Food, Drug & Cosmetic Act.

Keep Up to Date in a Changing World

Do you want to receive more valuable insights directly in your inbox? Visit our subscription center and let us know what you’re interested in learning more about.
Subscription Banner