This program was updated on July 1, 2026, & there were 133 devices registered in the FDA TAP Pilot. Where TAP is strengthened to receive enrollment requests around all Offices of Health Technologies (OHTs) for Breakthrough-designated and Safer Technologies Program (STeP) devices that fulfil TAP enrollment criteria explained below.
Recently, the FDA Center for Devices and Radiological Health (CDRH) rolled out the voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot to support accelerated progression of high-quality, safe, effective, and novel medical devices critical to public health. This program is one of the devotions among the FDA & industry as part of MDUFAV reauthorization.
TAP is expanding with a prominent aim to speed up patient access to these groundbreaking medical devices by offering prior, often, & strategic communications with the FDA, along with a tie-up with other major parties for innovators of devices of public health importance. TAP is achieving this goal through a committed cadre of FDA TAP advisors, who proactively offer solutions-aimed engagement that is personalized to each TAP innovator’s requirements in reinforcing devices to market & patient access.
According to Towards Healthcare, the North America pre-clinical scientific research medical device market is projected to experience significant growth, with estimates suggesting the market size will increase from USD 10.17 billion in 2026 to approximately USD 18.38 billion by 2035, representing a compound annual growth rate (CAGR) of 6.8% from 2026 to 2035. Enforcement of stricter testing standards for biocompatibility, sterility & performance by the FDA is driving the need for comprehensive pre-clinical trials before human clinical trials. Gradually surging outsourcing to manage specialised in vitro & in vivo testing finally lowers operational expenses & accelerates regulatory approval periods.
Emerging technologies & review programs are supporting the overall market development to explore novelty in medical devices.
According to Towards Healthcare, the North America pre-clinical scientific research medical device market has been emphasizing innovative technologies, including integrated AI, robotics, & complex biomaterials into connected/wearable devices & implants. This needs multi-disciplinary preclinical testing, evolving new opportunities across the North American nations. Alongside, the market is enforcing new programs, like the FDA's Breakthrough Devices Program, which spur rapid, interactive development and rapid commercialization pathways.
