Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in FDA Week, in “FDA Heads Call for Flexible Regulatory Framework for Medical Software,” by David Roza. (Read the full version – subscription required.)
Following is an excerpt:
Top FDA officials, including FDA Commissioner Scott Gottlieb, reaffirm the need for a new regulatory framework for software as a medical device (SaMD), which they hope will help ease the regulatory uncertainty surrounding such products, increase consumer confidence in the technology, help payers and investors understand the technology, and allow the agency to keep up with the fast pace of software development.
In a Monday (July 2) article in the Journal of the American Medical Association (JAMA), Gottlieb, FDA device center Director Jeffrey Shuren, and Associate Director for Digital Health Bakul Patel reiterate FDA’s commitment to explore a firm-based approach to regulating digital health technologies, a move that industry lawyers have said would require a cultural shift at FDA.
Brad Thompson, an attorney with Epstein Becker & Green, said that the JAMA article provides a logical explanation for why FDA is interested in a new approach to SaMD, but he said the article left out: the agency’s refusal to exempt some low-risk software from regulation; how FDA would enforce its software precertification program; and how the agency justifies the pre-cert program in statute.
Thompson applauded the reasoning agency officials gave for a new approach to SaMD. The officials wrote: “[T]he regulatory framework enacted by Congress in 1976, and incrementally improved since then, is not well suited for software-based technologies, including mobile apps, what FDA and other regulators call [SaMD]. Congress’ regulatory framework was designed for hardware-based technologies. For these devices, developers may only modify products every few months to years.” …
The officials point out that not all medical apps are under FDA’s regulation. In May, the agency opened a public docket to gather input on non-regulated apps, such as those that make general wellness claims, to gauge their effect on patient safety. However, Thompson said FDA has yet to exempt some low-risk software, such as low-risk clinical decision support software, which he said Congress directed the agency to exempt from regulation in the Food and Drug Administration Safety and Innovation Act (FDASIA).
“And that’s very disappointing,” the attorney said.
Thompson also is disappointed by FDA officials’ depiction of the precertification program, which he said “offers nothing but additional burden” for low-risk software, and which would require FDA to conduct invasive inspections of a developer’s business practices. The attorney said that is outside the agency’s statutory authority.
“The agency has been focusing on the things it anticipates industry will like [such as streamlined approval pathways], while holding back discussion of the things it knows industry will not appreciate,” Thompson said. “This includes the whole enforcement side of FDA’s function in the context of the precert program ... [I]n its latest working document, FDA asserts that it thinks it will be able to proceed without statutory or regulatory authority. How is that possible?” Thompson asked.
