FDA Device Advice
Expect Greater FDA Enforcement of 510(k) Summary Content
Written by: Lisa KingMonday, January 25th, 2010 | FDA Medical Device Regulations | No Comments
It may be time for sponsors of 510(k) premarket notifications to revisit the fundamentals.
MDCI has learned that CDRH review staff have been directed to pay closer attention to 510(k) Summary content and that FDA is now including a reminder about 510(k) content in its standard Agency letters verifying receipt of 510(k) premarket notifications.
While there has been no formal announcement of this closer scrutiny, our review of the relevant Device Advice page revealed that information about 510(k) summaries was updated on January 8, 2010 and now directly reflects the information specified in 21 CFR 807.92. The updated Device Advice content is available here. › Continue reading
Subscribe via Email
Search
Contributors
Categories
Archives
Recent Posts
- FDA Publishes Rule to Require PMA or PDP for Four Class III Preamendment Devices
- Industry Slow to Respond to FDA Call for Infusion Pump Assurance Case Reports and Clinical Evaluations
- FDA Update - CDRH Issues Medical Device Recommendations
- Q1 Conference in Baltimore Highlights FDA Regulatory Challenges for Combination Products
- FDA Could Tighten Focus on Human Factors Testing for Medical Devices