FDA submission communications guidance

FDA issued a final guidance on April 4, 2014 titled “Types of Communication During the Review of Medical Device Submissions”. This guidance provides a clear descrition of the stages of a premarket review, timing, and information communicated including the forms of communications. In states that the initial acceptance for review stage timing does not begin until any user fee and an ecopy is received. Whether accepted for review or rejected FDA will provide the name of the lead revieweror regulatory project manager. The next stage is substantive interaction and FDA will notify at the end of its review whether interactionw ill be interactive or by placing the submission on hold and providing a list of deficiencies. Interactive review does not affect the review clock and does not restrict issues to minor ones as in the ealrier draft. Email and fax are the preferred interactive review communication methods with limited use of phone calls for brief clarification requests.

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