The US Food and Drug Administration (FDA) has initiated a soft launch of its Total Product Lifecycle Advisory Program (TAP), which was negotiated under the latest Medical Device User Fee Amendments (MDUFA V) deal. The agency has updated its website with details about how to apply for the pilot program and its plans to expand the program over the next five years.
On 1 January, FDA launched its TAP pilot program that would allow sponsors to get feedback from external stakeholders such as physicians and insurers on how to bring successful products to market. The medtech industry was initially strongly resistant to the idea when it was proposed during the MDUFA V negotiations, but the agency argued it would help device and diagnostics sponsors better prepare their products for market. In the end, both sides agreed to do a soft launch of the TAP program rather than a full launch to test its feasibility. (RELATED: FDA will begin accepting breakthrough devices for TAP pilot in 2023, Regulatory Focus, 11 October 2022)…
