Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MedTech Dive, in “FDA Wants New Companies to Help Test Its Pre-Cert Program,” by David Lim.
Following is an excerpt:
To qualify as a test case volunteer companies must be in good standing and not have outstanding compliance actions, have a track record in developing software, agree to provide variety of information to FDA and have a De Novo or 510(k) for SaMD ready for submission by June 2020.
But one attorney familiar with the program said its future is uncertain.
“Given the extraordinarily slow pace of — and little progress in developing the program over the last couple of years — and the fact that they will need legislative authority, the future the program is quite uncertain,” Brad Thompson, an attorney at Epstein Becker Green, told MedTech Dive.
“I imagine that some companies will want to get in on the ground floor the program, gaining experience early on,” he said. “But, obviously, that only makes sense if you believe this program will ever come to fruition.”
Thompson also questioned why a company would want to participate in testing the Pre-Cert Program given what he said is a more burdensome path to market for companies. FDA said in its announcement it “does not intend to provide precertification for companies during the testing in 2019.”