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FDA releases new draft guidance on Refuse to Accept 510(k) policy

08/23/12

The FDA has released an update to the 1993/1994 Refuse to Accept 510(k) policy (RTA), which is open for comment until September 27, 2012. The purpose of the RTA policy is to provide guidance for industry on the criteria that the FDA uses to initially assess a 510(k) submission and recommend for further review to accept the application.The previous RTA guidances contained broad criteria that often resulted in the review of incomplete applications that cost FDA investigators time and resources to obtain all required information.

In response to the MDUFA III agreement to increase medical device approval rates, the FDA has updated the RTA policy to include an early review process and require that the FDA inform the submitter within 15 days of submission that the application is complete. In addition, this guidance provides specific criteria for the information required for a complete 510(k) application to reduce the number of inadequate applications.

Read the full guidance and to submit comments.