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Talk Now: FDA Finalizes Guidance On Pre-Market Communications

The guidance, which is very similar to a proposed version from last year, updates the interactive review program, and describes three relatively new points of communication between FDA and a device sponsor during the review process.

A final guidance mapping out FDA’s new approaches to communicating with device submission sponsors during the pre-market review process closely matches a proposal issued by the agency last year.

FDA published the guidance on “Types of Communications During the Review of Medical Device Submissions” April 4, finalizing the draft version from March 2013.

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