FDA Releases Guidance for Handling Post-Approval Studies Imposed by PMA Order

Summary

The Food and Drug Administration (FDA) has released a guidance document outlining procedures for handling post-approval studies mandated by premarket approval applications. The guidance aims to standardize the submission of post-approval studies, ensuring sponsors provide sufficient information and facilitating the tracking and evaluation of these studies by the FDA's Center for Devices and Radiological Health (CDRH).