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Comments Sought on Device Pre-Submission Program


Federal Register Notice: FDA is seeking public comment on requests for feedback submitted under the Pre-Submission program for medical devices. A guidance on the topic provides recommendations on the information that should be submitted in a Pre-Submission package and procedures that should be followed for meetings between CDRH and CBER staff and industry representatives or application sponsors. In addition to Pre-Submissions, the guidance addresses other feedback mechanisms including Informational Meetings, Study Risk Determinations, Formal Early Collaboration Meetings, and Submission Issue Meetings and the procedures to request feedback using these mechanisms. Comments should be submitted by 9/26. To view this notice, click here.