FDA’s final guidance on Post-Market Surveillance


FDA’s final guidance on Post-Market Surveillance

FDA has published a final guidance regarding post-market surveillance requirements, based on Section 522 of US Federal Food, Drug and Cosmetic Act.

This final version authorizes the FDA to require post-market surveillance Plan  for Class II and Class III devices, which could cause serious adverse events; which are used in pediatric population, which are intended for implantation in humans for more than one year and which are intended for life- saving or life-sustaining outside the healthcare facilities.

In the definition of FDA’s post-market surveillance order is involved a team, called pre- 522 team, which include epidemiologists, clinicians and other experts.

Once FDA issues an order to conduct a post-market surveillance program, the device manufacturer must initiate the activity no later than 15 months from that order.