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Chatting With FDA: New Draft Guidance Addresses Communications During Device Reviews

The document updates FDA’s “interactive review” program, expanding uses of the approach and describing three additional types of review-process communications.

Companies that have submitted a pre-market device submission to FDA should be hearing from the agency more often during the review process under the new user fee program, the agency says. A new draft guidance from the device center describes more precisely when sponsors should expect reviewers to drop them a line.

The document, on “Types of Communications During the Review of Medical Device Submissions,” was issued March 4. It’s an update, of sorts, to FDA’s “interactive review” policy, which allows FDA...

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