How to Effectively Use FDA’s Presubmission Process

Earlier this year, FDA issued the final guidance, “Requests for Feedback on Medical Device Submissions: The Presubmission Program and Meetings with Food and Drug Administration Staff.” This program allows for a variety of different presubmissions and meetings with FDA, including those to educate FDA or to discuss the plans for a premarket submissionsuch as a 510(k) notification, de novo petition, or premarket approval (PMA) application or testing, including clinical study plans.

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