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FDA issues guidance on post-approval studies

Device Regulation Alert: Safety, Compliance and Reimbursement News, September 10, 2007

The FDA can condition pre-market approval on post-approval studies to generate reports on the safety and effectiveness of a device.

In August, the FDA provided guidance to sponsors and FDA staff about the form, content, and review of such post-approval study reports. That guidance supersedes guidance issued in December 2006. The goal, according to the FDA, is to make those studies effective and efficient. The FDA's guidance focuses on clinical post-approval studies rather than animal or laboratory bench studies.

The guidance seeks to

• achieve consistency in post-approval reporting
• assist in identifying and tracking post-approval studies
• improve FDA/sponsor communication about study purposes and challenges
• help resolve issues arising with regard to post-approval processes.

While the FDA guidance isn't mandatory, it helps reveal the FDA's thinking about post-approval studies. It suggests the types of information sponsors should submit concerning such studies. The guidance is also intended to "increase the transparency of CDRH's [Center for Devices and Radiological Health] approach to post-approval study requirements" and improve communication about these studies.

The FDA provides the guidance in the form of answers to questions such as

• when to submit post approval study protocols
• what happens when a sponsor doesn't finish a post-approval study
• what information sponsors should include in post-approval study reports
• when to submit interim status reports and final reports on post-approval studies
• how CDRH evaluates interim status reports and final reports
• what study-related information will be made public

Click here to review the guidance.

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