How to Effectively Use FDA’s Presubmission Process

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

Allyson 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:

  1. Request a meeting. Putting a face to the names at the company and FDA can never hurt. Also, FDA generally provides written feedback to a presub regardless of whether a meeting or written feedback is requested, so the meeting is an added bonus.
  2. Have a fresh set of eyes review. It’s easy for those within a company that are familiar with the technology and the proposed regulatory strategy and/or testing plan to lose sight of the bigger picture, such as what the questions of safety and effectiveness are that the testing is intending to answer. A fresh set of eyes can help ensure that your message and—sometimes more importantly—your questions are posed in such a way to obtain the information that you need.
  3. Practice, practice, practice. Before meeting with FDA, ensure that you know your presentation and what you want to get out of your meeting. 

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.

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