FDA’s presubmission program and meetings present a valuable opportunity for companies to gain clarity and nonbinding feedback on premarket submissions and testing plans.
By Allyson B. Mullen
Earlier this year, FDA issued the final guidance, “Requests for Feedback on Medical Device Submissions: The Presubmission Program and Meetings with Food and Drug Administration Staff.” This program allows for a variety of different presubmissions and meetings with FDA, including those to educate FDA or to discuss the plans for a premarket submission—such as a 510(k) notification, de novo petition, or premarket approval (PMA) application—or testing, including clinical study plans.
A presub meeting can be immensely helpful when used effectively. When a company has a new technology or when its technology is being developed for a new use that FDA may not be familiar with, it can be tremendously useful to meet with FDA and educate the agency on the new technology.
Later in the regulatory process, when the company is preparing for a premarket submission and/or establishing its testing plan for the new medical device or IVD product, it can use the presub program to gain early, nonbinding feedback from FDA as to its submission strategy, types of testing planned, and the test methods to be employed. Feedback obtained from a presub can give companies some confidence that the data they generate and their regulatory strategy will be in line with FDA’s expectations.
While the presub program can be tremendously useful, it is easy for companies to squander the opportunity. Companies often overload FDA with too much information and forget to pose strategic questions to solicit key responses from the agency. Here are three tips for using the presub program effectively:
When struggling with the increasingly complex regulatory system in the United States, medical device manufacturers should take advantage of the presub program to provide guidance and help avoid costly errors and delays.
|Learn more about the advantages of presub meetings and other regulatory affairs issues at the MD&M East conference, June 9-12, in New York City.|
Allyson B. Mullen is an associate at the law firm Hyman, Phelps & McNamara, P.C., where she provides counsel to medical device and IVD manufacturers.