Increased Focus on Postapproval Trials Prompts Guidance

As part of increased agency attention to postapproval studies, sometimes required for product approval, the FDA has issued new guidance addressing the study reports that manufacturers must submit at regular intervals.

Center for Devices and Radiological Health may require a postapproval study, also referred to as a condition-of-approval study, when reviewing a premarket approval (PMA) application for a device.

The new guidance, which replaces a previous draft guidance, provides recommendations to industry and reviewers on the format, content and review of reports on clinical studies required for PMA application approval.