Since the FDA’s establishment, it has committed to ensuring each user in America operates medical devices with safe conditions. Depending on the device's potential risk or other factors, FDA has built a different channel or method for registration.
For safety reasons, the FDA requires high risk medical devices or devices with an exempt report to submit a post-market track report after the devices are sold in the USA. It is called the “Post-Approval Studies", whereby the FDA will ask for the plan of post-approval studies when product owners submit the application to get approval.
Applicants for Premarket Approval (PMA), Humanitarian Device Exemption (HDE), or Product Development Protocol (PDP) might be required to submit action plans for the post-approval studies. Among these applications, PMA is the main one that the FDA is most concerned of.
In general, these post-approval studies need to fulfil the following requirements:
- Applicants who produce post-market studies must follow reliable science methods.
- Follow the timeline to submit the result of the studies to the FDA.
- The FDA provides appropriate public notification of study information
To simplify the process of post-approval studies, the FDA has also established a database system. In this system, the applicants can keep track of their device's plan for post-approval studies and timeline, as set by the FDA. In the worst case that the applicant fails to fulfil this requirement, the FDA could cancel the medical device’s approval that each applicant must take note of.
- Post-Approval Studies Program
- Procedures for Handling Post-Approval Studies Imposed by PMA Order-JUNE 2009
- September 2015 GAO Report: FDA Ordered Postmarket Studies to Better Understand Safety Issues, and Many Studies Are Ongoing
- Post-Approval Studies Database