Ophthalmic Devices to be Included in FDA TAP Program

The US FDA announced July 1 that it was expanding its TAP pilot program in October to include ophthalmic devices, as well as radiological health devices.

The voluntary program, officially named the Total Product Life Cycle Advisory Program, is designed to spur more rapid development of devices by reducing the time and cost of the approval process and increasing the predictability of the outcome.

TAP is structured to provide early, frequent, and strategic communications with the FDA, plus help developers work with patients, providers, and payors.

The FDA created the new role of TAP advisors with expertise across all areas of product development to provide near-real-time feedback to developers.

The program is limited to devices with breakthrough designation and has enrolled 46 devices to date, first focusing on those in cardiovascular and neurological areas.

The Center for Devices and Radiological Health (CDRH) launched the pilot program in 2023.

TAP will add orthopedic devices in 2025.

Jeff Shuren, MD, JD, director of CDRH, said in a promotional video that TAP addresses the challenges of product development—“essentially the valley of death going from concept to commercialization.”

Shuren said developers currently can “seek advice from the FDA through pre-submission meetings, but those are kind of stage gated. You send in your questions, and then within 70 days we’ll provide you with a response, and we’ll meet with you. If you have more questions, you throw them back over the transom, and that process starts all over again.”

Conversely, the TAP advisor will engage proactively and strategically, even independently reaching out to the developer to start to identify the key challenges and questions and then strategize on how best to address them to be successful, Shuren said.