FDA’s Final Guidance for the Pre-Submission Program: Early Experience and Lessons Learned

The U.S. Food and Drug Administration’s (“FDA”) Center for Devices and Radiological Health (“CDRH” or the “Division”) released its final guidance on February 18, 2014, entitled Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with the Food and Drug Administration Staff. This final guidance supersedes the Blue Book Memo D99-1 Pre-IDE Program: Issues and Answers, dated March 25, 1999.

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