US FDA's Software Pre-Cert Program: Is The Authority On The Books?

US FDA's Software Pre-Cert Program: Is The Authority On The Books?

July 31, 2018, Medtech Insight

Wade Ackerman is quoted in Medtech Insight regarding the FDA’s software pre-certification program and what that means for device and digital health firms interested in getting new products to the market. Mr. Ackerman says, "The agency has been transparent in that it is considering various legal mechanisms available to the agency to establish the program – recently saying it plans to use FDA's current statutory and regulatory authorities. Many stakeholders we're working with are interested to see how FDA will outline its legal approach to the program." Ackerman adds, “I think ultimately Congress may want a say on FDA's approach, as we’ve seen in many other contexts from accelerated drug approval to the digital-health provision" in the 21st Century Cures Act.”