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

By Jim Dickinson

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.

 [image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]