December 6, 2022
The US Food and Drug Administration announced that it has launched a pilot program designed to foster earlier conversations in the medical device product lifecycle between the agency and manufacturers. The intent is to provide input into product development and lessen the time it takes to bring innovative new devices to market. The Center for Devices and Radiological Health (CDRH) runs the Total Product Life Cycle Advisory Program, referred to as the TAP Pilot.
The TAP Pilot is voluntary for medical device makers that qualify during the soft launch which begins January 1, 2023. For the first year of the pilot, only 15 cardiovascular devices will be admitted into the program through the Office of Health Technology (OHT2): Office of Cardiovascular Devices. According to the FDA, when sponsors go through the Breakthrough designation process or inclusion in the STeP process, they will be invited to apply for the TAP Pilot. The OHT2 was selected for the first year of the TAP Pilot because historically it gets the greatest number of breakthrough device designations, as well as the most staff and funding.
The intent of the FDA is to expand the pilot into other OHTs as the program grows and develops.
What are the goals of the TAP Pilot?
According to the FDA, some of the most critical goals of the pilot include collaborating to identify device development risks earlier, to better align expectations regarding evidence generation, improving submission quality and improving the efficiency of the premarket review process.
The agency has set these goals for TAP:
- FY 2023: enroll up to 15 products in a soft launch in one Office of Health Technology (OHT).
- FY 2024: continue to support products enrolled in the previous fiscal year and expand to enroll up to 45 additional products in at least two OHTs.
- FY 2025: continue to support products enrolled in the previous fiscal years and expand to enroll 65 additional products in at least four OHTs.
- FY 2026 – FY 2027: In addition to the above, the selection of the OHTs will be made with consideration of prior years and input from industry and other stakeholders.
How will the TAP Pilot be measured?
The FDA has said that it intends the TAP Pilot to demonstrate the benefits of the process improvements from the agency’s interactions with participants and stakeholders. The TAP Pilot will be assessed using a third party or parties. The assessment will include a participant survey and quantitative and qualitative success metrics starting in FY 2024.
Submit feedback about the TAP Pilot
All stakeholders, including pilot participants, are invited to provide feedback on the TAP Pilot to inform the direction of the pilot. You may submit feedback under docket number FDA-2022-N-2274 by January 9, 2023 at www.Regulations.gov.
Emergo by UL will continue to post updates to FDA guidance as they become available.