Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MobiHealthNews, in “FDA Looks to Restrict Older Predicate Devices, Introduce New Regulatory Pathway,” by Dave Muoio.
Following is an excerpt:
Yesterday, the FDA announced in a press release that it is eyeing potential updates to the agency’s 510(k) clearance pathway for medical devices. These could include a requirement for more modern predicate devices as well as objective safety and performance criteria during regulatory submission. …
Bradley Merrill Thompson, a lawyer at Epstein, Becker & Green who counsels on FDA regulatory issues, described Gottlieb and Shuren’s statement as the latest in “a very troubling pattern” of the FDA acting beyond its scope. In an email to MobiHealthNews, he explained that phasing out old devices would be “essentially forcing companies to innovate regardless of whether the marketplace perceives a need,” thereby driving healthcare costs with unnecessary R&D.
“Frankly, I think that spurring innovation typically out to be led by the marketplace,” he wrote. “In other words, users are in the best position to demand innovation, and reward it with customer loyalty. Regulators prevent downside risk, but upside innovation is generally the product of the marketplace. FDA has not made the case that for some reason the marketplace cannot operate effectively to encourage innovation, and that the lack of innovation is actually causing the problem.”
Thompson also noted that if the agency truly believes that new regulatory efforts are necessary to drive the market, it would need to make a case to Congress for an update to the Medical Device Regulation Act of 1976 rather than act on its own.
“The 1976 statute is very clear, and FDA can’t simply ignore it,” he wrote. “If FDA wants to change the statute, then to Congress they should go. Congress in turn could bring together all of the various stakeholders including patients, healthcare professionals and medical device manufacturers to talk about the … need and the best way to do this. FDA has no mandate to do this on its own.”