A draft guidance published May 17 describes the type of information FDA will provide in the substantive summary it is legally obligated to provide to a device company seeking to know the rationale behind a pre-market review decision.
The document, “Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A,” offers FDA’s interpretation of the...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?