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Southeast Life Sciences Taps New FDA Breakthrough Program

The Southeast Life Sciences Conference in May 2022 in Atlanta, Georgia focused on the new FDA Tap program to accelerate early-stage medtech. Read on here.
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The Southeast Life Sciences Conference in May 2022 took place in Atlanta, Georgia, and focused on the Total Product Life Cycle (TPLC) Advisory Program, a new FDA initiative created to accelerate early-stage medtech. “The long-term vision for a successful TPLC Advisory Program (TAP) is to help spur more rapid development as well as more rapid and widespread patient access to safe, effective, high-quality medical devices of public health importance. A mature TAP will also help ensure the sustained success of the breakthrough devices program. A significant feature of the TAP pilot is that it would offer regular, solutions-focused engagement between medical device developers and patients, healthcare providers and payers."1

The FDA’s TAP program for breakthrough designated products/devices “combines early stakeholder input, strategic advisory services, real-time communications and radical transparency to dramatically reduce the risk, time and cost of early-stage medtech while producing more financially sustainable companies and better characterized, safer and more effective products for the patient population.”2 TAP is a pilot program designed to decrease go-to-market timelines, and it is only for breakthrough therapies based on FDA guidelines.

The TAP Program will begin in October 2022 (fiscal year 2023) and run through September 2027. Each company can enroll only one product per fiscal year, and it must be in the early development stages with no trial history. “The program will begin with a soft launch in 2023 with up to 15 products in a single Office of Health Technology. The process to choose that office will include a consideration of each office’s previous volume of breakthrough designations as well as their workloads and available staffing and expertise.”3

Each year the TAP Program will continue to support the products from the prior year while offering new product enrollees an opportunity to join the program. In 2024, up to 45 additional products will be added to the program in two or more Offices of Health Technology, bringing the total to 60 products. Also in 2024, industry leaders and stakeholders will provide input into the selection of Offices of Health Technology. By pilot completion in 2027, there will be up to a maximum of 325 products across multiple Offices of Health Technology.

“The FDA will track qualitative and quantitative success metrics throughout the pilot, regularly reviewing progress with the industry and assessing the results and opportunities for improvement. An independent third party will conduct an assessment of the program to be published by the FDA no later than January 30, 2026.”4Other performance tracking considerations include a participant survey assessment to measure the timeliness and quality of communication and other interactions with the FDA and its non-FDA stakeholders.

How Forvis Mazars Can Help
Breakthrough technology product discoveries will require financial backing through government grants, venture capital or private equity investments, and other private sources and partnerships. Forvis Mazars can assist life science companies seeking funding with establishing governance, grant management, valuation, financial statement audits, and more. For questions on how we can support growth in your life science company, reach out to a Technology & Services professional at Forvis Mazars or submit a request through our contact us form.

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