On February 18, the FDA issued the final guidance document for the Pre-Submission Program and Meetings with FDA Staff. The Pre-Submission process is a way for industry to get feedback from the FDA prior to the submission of a premarket application (PMA, 510(k), HDE, IDE, de novo, etc.). The sponsor may submit a pre-submission application to the FDA requesting answers to various questions about the marketing application or clinical trial design of their device. The sponsor may request a written response, teleconference, or meeting. The FDA has committed respond to the sponsor within 75 to 90 days.
[fa icon="clock-o"] 2/21/14 4:09 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] Q-Sub, FDA, Guidance Document, Pre-Sub, PMA, 510(k), Pre-Submission
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