How to leverage the FDA’s newest pilot program for speed to market and post-approval market success
Just announced: the FDA will continue to grow its pilot TAP (Total Product Life Cycle Advisory Program), which currently has 15 devices accepted. Starting October 1st, the FDA will accept applications for an additional 45 Breakthrough Devices through the Office of Cardiovascular Devices (OHT2) and the Office of Neurological and Physical Medicine Devices (OHT5).
What is the TAP Program?
TAP came out of the agreement between the FDA and the medical device industry (MDUFA V) to test drive improvements in the medical device approval process. And this is not just a bureaucratic feel-good initiative — there is real accountability baked inside — with improvements measured and reported by an outside 3rd party.
The program’s mission is, as always, patient-centric:
The FDA’s plan to achieve that mission is through early and fast interactions between device makers and the FDA, and “strategic engagement with non-FDA stakeholders”.
Non-FDA stakeholders = Industry Buy-In
In our opinion, the most exciting and valuable part of the TAP program is the inclusion of non-FDA stakeholders. What it means is that the FDA will coordinate and introduce TAP device makers to these groups/societies who have formally opted-in to the program:
American Association of Neurological Surgeons (AANS)
American Association of Kidney Patients (AAKP)
American Brain Coalition
American College of Cardiology (ACC)
American Medical Association (AMA)
Congenital Heart Surgeons’ Society (CHSS)
Congress of Neurological Surgeons (CNS)
Heart Rhythm Society
International Children’s Advisory Network (iCAN)
North American Neuromodulation Society
The Mended Hearts, Inc.
Pediatric and Congenital Interventional Cardiovascular Society
Society for Cardiovascular Angiography and Interventions (SCAI)
Society for Vascular Surgery (SVS)
Society of Thoracic Surgeons (STS)
This allows device makers to get buy-in from established societies, which could potentially mean access to early adoption, research opportunities, incorporation into professional guidelines, publications, and obtaining codes for reimbursement.
The FDA is just making the introduction, not making a guarantee that a society will support a TAP device. It is up to the device maker to make the most of these introductions.
Improvements by the Numbers
Another benefit of the TAP program is that the piloted process improvements are measured by an independent 3rd party. They will be collecting and reporting data on participants overall satisfaction, their products’ successful outcomes, as well as the FDA’s success meeting these 3 metrics:
90% of requests for a phone call are met within 14 days
90% of requests for written feedback on biocompatibility and sterility are met within 21 days
90% of requests for written feedback on other issues are met within 40 days
Knowing that you can quickly get answers, and that your market success and program satisfaction actually matter, are what make the TAP program so appealing and potentially incredibly valuable.
Any Downsides?
Unfortunately, this is a small pilot with an uncertain future — it may become permanent, or it may be discontinued. It is also available only for 2 OHTs now, with more to come. It is also only open to devices regulated by CDRH, not those regulated by CBER (Biologics) or combination products.
There are a few restrictive criteria for timing as well: devices must be granted Breakthrough Designation, devices must be early in development (no pivotal study done), they cannot have already filed a pre-submission, and device makers can only have 1 device enrolled at any time.
Of course, with any brand-new program, there is the risk of not having a well-worn path; however, we think the potential benefits far outweigh any risks, so if you are on the fence we would encourage you to apply for the TAP program.
How do I get into this program?
The TAP pilot will be enrolled on a first-come, first-serve basis. From the FDA’s guidance on how to get in, the application paperwork is minimal. Sponsors should submit an amendment to the Q-submission under which the device was granted Breakthrough designation, with the following information:
Subject heading “TAP Pilot Request for Enrollment”;
Name and address of the device sponsor; and
The Q-Submission number under which the device proposed for enrollment in the TAP Pilot was granted Breakthrough Device designation.
You’ll know within 30 days if you were accepted, and if you aren’t, FDA will tell you why not. If it’s because the program is full, perhaps there will be an opportunity to apply again in the near future.
Bottom Line
For now, the TAP pilot is small, but potentially highly beneficial for device makers, giving them faster FDA feedback, and early coordination with relevant industry groups.
We think TAP is a win all around for:
Device Makers: by significantly de-risking the approval process and speeding up the market adoption and reimbursement processes.
Non-FDA professional groups: allowing them to provide device development input early on — so they end up with a better final product.
Patients: better Breakthrough devices will be available (and potentially covered by insurance – see our previous article on the topic) much faster.
The TAP application window opened Oct 1st, 2023, and there is likely still room in the pilot for those that act quickly — but every day counts.
If you need help navigating that process, or to learn if your device could qualify for TAP or Breakthrough Designation, book a free consultation with one of PTL Solutions’ regulatory experts.
PTL Solutions can help with all your Q-submissions, even with the tight turnaround times of FDA requests for additional information. Let us help you craft a winning regulatory strategy that gets it right the first time.
Our team is highly experienced, with decades of experience guiding medical device manufacturers through the FDA regulatory process, and 80 products successfully brought to market. PTL will customize a path to market for your device that considers safety, speed, and budget.
Comments