This article was originally published in The Gray Sheet
Up to three guidance documents explaining FDA's proposed policy for arranging modular premarket approval applications with device sponsors are expected to be released in April, agency staffers say. Guidances for the policy, which was outlined by FDA Office of Device Evaluation Director Susan Alpert at a Feb. 25 videoconference ("The Gray Sheet" March 2, p. 5), will explain what constitutes a PMA "shell" and the modules needed to complete it; methods for assembling the summary of safety and effectiveness data; and requirements for labeling and proper closure of the process, FDAers indicate...
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