FDA Issues Updated Guidance for Pre-Submission Program

| Printer friendly version

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”).

Leave a Reply

By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.