If you are a regulatory person in the medical device industry, and you have a submission planned for either the U.S. Food and Drug Administration’s (FDA) investigational device exemption (IDE), De Novo, 510(k) or premarket approval (PMA) pathways, you are probably familiar with the agency’s Pre-Submission (Q-Sub) program. As a consultant I routinely assist clients with their Pre-Sub process.
A little history here. Device user fees were first established in 2002 by the Medical Device User Fee and Modernization Act (MDUFMA) that gave the FDA’s Center for Devices and Radiological Health (CDRH) had a new source of funding. They used it to hire new reviewers and scientists. But there is a catch. The FDA convinced Congress to pass MDUFMA with the promise that submission review times would be reduced. Each year, the FDA has to report to Congress on the review times for regulatory submissions. If they don't meet the goals, they lose the funding. If they meet the goals, the Act is authorized for another year.
The FDA realized that they must do something to assure they don't lose the user fees. Thus, the birth of the Pre-Sub meeting program. Under the program, the FDA advises firms designing a new device or in vitro diagnostic (IVD) how to use the Pre-Sub program. The FDA also provides guidance to companies on how to submit their regulatory strategy through the program and information about its process and requirements. Sounds like a pretty good deal. So, what is the problem?
Pre-Sub meeting requests are not data reviews. They allow you to tell the FDA in multiple Pre-Sub requests about your product design verification plans, proposed clinical trials, and any other issues that might come up in an FDA submission review. You can then ask specific questions about your plan and ask the FDA to comment on your questions. But there is no statuary time frame in which the FDA will respond. This can present a problem when the delays in the FDA’s response cause delays in product development.
I have faced the problem with clients whom I have directed to the Pre-Sub, and the delays have been problematic for them. But they are manageable if you relate to your company or client the clarifications I provide in this article.
Is it mandatory to use the Pre-Sub program? No, it is not. You can proceed as you did prior to 2002. Prepare your regulatory submission, send it to the FDA, and then the FDA will tell you what additional information documentation is needed, a required step to gain permission to sell your device. Review times increased significantly under this older process, especially when the FDA requested data that took considerable time to compile and submit. Those long review times needed to be planned into a company’s product schedule. The FDA needed more people to speed up the reviews, which spurred the passage of MDUFA.
If you use the Pre-Sub program as the FDA encourages, your IDE or marketing application will almost always be reviewed within the statutory time frame of 30 days for an IDE and 90 days for a 510(k). Equally as important, by using the Pre-Sub you build a relationship with your FDA reviewer and gain their favor by allowing the agency to start their review of your device well before the submission arrives. Going the Pre-Sub route also allows the FDA to report review times to Congress, which will in turn support the renewal of the user fees. These are results that can well serve your company’s device compliance and approval process.
I encourage the use of the Pre-Sub program and planning for the Pre-Subs as part of your device’s development plan. The total time to use the Pre-Sub program and get a speedy review is no longer than previously when submissions often resulted in numerous requests from the FDA for additional information. But the difference now under the Pre-Sub program is that not only is the FDA your friend, but you’ve also helped them retain their funding from user fees. It’s essentially a win-win for both parties.
J. Lawrence Stevens, RAC and principal consultant at One Way Consultants, has a unique background of U.S. Food and Drug Administration (FDA) and industry experience. He has over 20 years of FDA experience encompassing virtually all of the FDA field positions. Stevens also has 18 years of industry experience as a mid-level manager and senior executive in the clinical, regulatory, and quality areas of the medical device industry. He has personally designed quality systems, prepared regulatory submissions, including 510(k), IDE and PMA, and managed seven multi-center clinical trials for Class III medical devices. From 1989-1993, Stevens was the industry representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular devices. He regularly performs webinars on the FDA and issues regarding clinical studies and medical devices. Stevens is also a seasoned speaker/education having given over 250 public presentations to audiences ranging from senior executives, physicians and other medical staff, technical personnel, major media and the general public. Stevens currently serves as an expert witness for cases involving FDA regulation compliance for medical devices.
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