Medical Device News and Insights

Expect Greater FDA Enforcement of 510(k) Summary Content

Monday, January 25th, 2010 | FDA Medical Device Regulations

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.

The updated Device Advice page recommends the following:

“If you choose to meet the conditions for a 510(k) summary (21 CFR 807.92), it must be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. As required by section 807.92(a), FDA will accept summaries or amended summaries until FDA issues a determination regarding substantial equivalence.  The 510(k) summary must contain the information described below. Please make a copy of the following to use as a checklist and check off each item to make sure your summary is adequate and complete.”

MDCI’s random inspection of 510(k) Summaries for medical devices cleared by CDRH between December 1, 2009 and December 31, 2009 shows considerable variation in the content and compliance of these summaries with the current document specifications.

Tags: 21 CFR 807.92, 510k submissions, 510k summary, CDRH, FDA Device Advice, FDA enforcement

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