On May 16, 2016 the FDA published the updated guideline “Postmarket Surveillance under section 522 of the Food, Drug and Cosmetic Act”.
This guidance is applicable when FDA officially orders to the class 2 and class 3 medical device manufacturers to execute post-market surveillance and reporting activities.
Some of the main articles of this new version are listed here below:

  1. After the approval of the registered device, the FDA can order to perform post-market surveillance at any time. This order must be executed within 15 months from the emission.
  2. Manufacturers can require changes to the surveillance program approved by FDA.
  3. Once evaluated, FDA can send many types of “decision letters” in order to approve the changes
  4. FDA can disclose data and analysis report in order to protect the patient.


For further information: