by ptlsolut | Oct 31, 2023 | FDA Programs
Is STeP right for your medical device? In 2021, due to the success of the Breakthrough Technologies program, the FDA created a new program called the Safer Technologies Program (STeP) to bring medical devices to market faster for conditions that are less serious than...
by ptlsolut | Oct 23, 2023 | FDA Programs, Regulatory Strategy
How to leverage the FDA’s newest pilot program for speed to market and post-approval market success Just announced: the FDA will continue to grow its pilot TAP (Total Product Life Cycle Advisory Program), which currently has 15 devices accepted. Starting October 1st,...
by ptlsolut | Oct 11, 2023 | FDA Programs
But fast-track designation still may not be the best path to market. On September 14, 2023, FDA watchers were scrambling to parse new guidance issued by the FDA regarding their Breakthrough Devices Program. The exciting news: there are now even more ways to qualify as...
