Dear Registered Establishment,

 

Today the FDA issued draft guidance document on the types of communication that occur during the review of medical device submissions. During the MDUFA III discussions, representatives from the medical device industry called for more transparency into the review process. This draft guidance document describes three new types of communications that will occur during the review of medical device submissions and updates our interactive review.

 

For more information, see Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication during the Review of the Medical Device Submissions.

 

Please submit comments within 90 days to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov

 

Thank you for your support of the FDA and our mission.

 

U.S. Food and Drug Administration

Center for Devices and Radiological Health