CDRH and CBER Issue Joint Guidance on Seeking FDA Feedback on a Planned Device

Posted in Regulatory and Compliance by Jamie Hartford on February 26, 2014

By Jim Dickinson
A joint CDRH/CBER guidance issued February 10, 2014, provides an overview of the mechanisms available to applicants for requesting feedback on a planned medical device, IDE, PMA, or 510(k).
The document, “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff,” provides information on the logistics for submission, receipt, tracking, and review of the requests.
The feedback mechanisms addressed in the guidance include presubmission meetings, informational meetings, study risk determinations, formal early collaboration meetings (i.e., agreement and determination meetings), submission issue meetings, and PMA day 100 meetings. For some of these, the document refers to existing guidance, while for others, it establishes the procedures FDA intends to follow when providing feedback, according to the agency.
Jim Dickinson is MD+DI's contributing editor.

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