FDA’s answer to ‘valley of death’ risk for medical devices
The FDA recently announced its new TPLC Advisory Pilot program (TAP) to accelerate access to new medical devices. It was definitely a hot topic at the FDA Town Hall held during this year’s MedTech Conference in Boston.
TAP is a new component of the Medical Device User Fee Amendment (MDUFA) V Agreement, which was signed into law on September 30, 2022. The purpose is to reduce delays getting innovative medical devices into the hands of practitioners and patients, or not at all due to complete failures during the early stages of development and clinical trials.
The program is designed to offer more timely premarket interactions with healthcare constituents including staff, patients, providers, and payers. There will also be an enhanced device development and review process to help flag and reduce product-development risk faster. Because there was industry pushback from an outright adoption of the TAP initiative, a 2-year pilot program was proposed and accepted.
Voluntary for applicants, a soft launch begins in January with a cohort of 15 devices from the Office of Health Technology 2 (OHT2): Office of Cardiovascular Devices. The FDA will track performance goals throughout the pilot, which includes a 90% on-time response rate, to monitor its substantial investment in the future of getting medical devices to market sooner.