Post Market Surveillance Plan – FDA
Post Market surveillance requirements are set out in Title 21 Code of Federal Regulation (CFR) Part 822. This section aims to put an adequate post-market surveillance authority into practice to increase the possibility that post-market surveillance (PMS) plans will result in valuable data gathering. These data can show unanticipated adverse events, the actual frequency of anticipated adverse events, or other details important for public health protection. FDA will assign a post-market surveillan...
