The Center for Device and Radiological health (CDRH) has released its guidance development plans for the 2015 fiscal year, with medical device clinical decision software included as a priority.
As in past years, the CRDH has divided the guidance documents into “A” and “B” lists, with those in the former list taking precedence over those in the latter list. Medical device decision-support software has now made its way from the B category a year ago to the A category this year. Once published, these guidances are the interpretations of the rules that the FDA expects industry to follow.
“It’s progress,” said Bradley Merrill Thompson, an attorney with the firm Epstein, Becker & Green in Washington D.C, who counsels medical device, drug and combination product companies on FDA regulatory, reimbursement, and clinical trial issues. “But it’s exceedingly slow progress.” Thompson pointed out the health IT industry has been urging FDA for years to move on issues like general wellness products, medical device accessories, and interoperability, as well as medical device decision-support software.
“The guidance on medical device decision-support software has been on the agency’s agenda since 2011,” Thompson noted. “It seems to be moving up the agenda—that’s the good news. But it has taken four years and that’s bad news for anyone trying to bring new technology to market.”
The ambiguity involved in not knowing whether FDA will regulate clinical decision support has “tremendous implications for business plans,” Thompson pointed out. “FDA regulation brings with it substantial additional costs as well as delays in market introduction. For companies that are raising venture capital or other investment to fund the development of CDS, being unable to tell investors whether the development cycle will be one year or two years, and whether it will cost an additional perhaps $250,000 to develop a quality system and conduct needed validations could be a problem. “
Thompson also suggested that the FDA will end up regulating a more “narrow and targeted” sector of the clinical decision-support software sector.
“I think FDA plans to rely on ONC (Office of the National Coordinator for Health Information Technology) to cover the majority of CDS, at least by volume,” he said. “I say volume, because I think they will rely on ONC to oversee some of the more popular, broadly used CDS. And I say ‘oversee’ because I don’t think ONC will ‘regulate’ in the sense of the word. They may set standards, but they are not an enforcement agency.”
Click here to see the CDRH Fiscal Year 2015 Proposed Guidance Development and Focused Retrospective Review of Final Guidance.