On February 18, 2014, the Food and Drug Administration (“FDA”) issued the Final Guidance “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” (the “Guidance”). On February 26, 2014, the FDA held a webinar regarding the Guidance and presented slides discussing some of its key provisions.
The Guidance includes information related to the FDA’s pre-submission program, which allows a medical device manufacturer to meet with the FDA for advice on its proposed products before submitting an application or conducting an important clinical trial. This allows medical device manufacturers to potentially avoid regulatory issues later on that might delay the processing of their applications.
An earlier draft of the Guidance had been issued on July 13, 2012 for public comment. The updated Guidance is significantly longer than the earlier draft, and includes information to address requests for FDA feedback and additional clarification for when it is appropriate to file various types of feedback requests.
The Guidance also includes appendixes for issues with specific types of applications, including Investigational Device Exemptions (“IDE”), 510(k)s, premarket approval applications (“PMA”), humanitarian device exemptions (“HDE”) and In Vitro Diagnostic (“IVD”) applications. The program has also been broadened to include devices regulated by the Center for Biologics Evaluation and Research (“CBER”).