Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Healthcare Dive, in “FDA Lays Out Next Steps for Pre Cert Pilot,” by David Lim.
Following is an excerpt:
The working model, deemed “Pre Cert 1.0,” is the first of several iterations, according to Gottlieb. The commissioner emphasized that continued input from developers, patients, providers, and members of the public is necessary for the program’s success. Once the first version of the program is in place, it will continue to be refined in 2019.
“The goal of this program is to develop a tailored and pragmatic framework that trusts the excellence of organizations, but also continually verifies the safety, effectiveness, and performance of software as a medical device,” Gottlieb said.
Brad Thompson, a medical device attorney at Epstein Becker Green, tells Healthcare Dive that the working model lays out what is effectively a trade between FDA and industry.
“FDA is proposing an expedited path to market, and in fact for some low risk software products an exemption from premarket review, in exchange for enlarging the agency’s authority,” Thompson wrote in an email. “Historically we’ve given FDA much greater power over the premarket decision, and much less power over the postmarket evaluation.”
