Types of Communication During the Review of Medical Device Submissions: Guidance for Industry and FDA Staff

Issue Date: April 4, 2014
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket,
Status: Final

Types of Communication During the Review of Medical Device Submissions: Guidance for Industry and FDA Staff

The Medical Device User Fee Amendments of 20123 (MDUFA III), amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to collect user fees for the review of certain premarket submissions received on or after October 1, 2012, including premarket notification submissions (510(k)s). The additional funds obtained from user fees will enable FDA, with the cooperation of industry, to improve the device review process to meet certain performance goals and implement improvements for the medical device review process. During discussions with representatives of the medical device industry in the development of the Agency’s recommendations for MDUFA III, the Agency proposed process improvements to provide further transparency for the review process, including new communication commitments. These additional communications are in the context of: acceptance review; substantive interactions; and, if applicable, missed MDUFA goals. These communications are outlined in the MDUFA III Commitment Letter and are further described in this guidance . In addition, this guidance updates the Agency’s approach to Interactive Review to reflect FDA’s commitments in the MDUFA III Commitment Letter and to incorporate an expanded use of this communication tool to increase the efficiency of the review process.

Download the Guidance Document