Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy, in “Senate User Fee Bill Sets Up New Path to Reclassify Device Accessories,” by David Lim. (Read the full version – subscription required.)
Following is an excerpt:
But Bradley Merrill Thompson, attorney at Epstein, Becker & Green, noted the legislation leaves the standard of evidence to support a reclassification up to FDA, something Thompson would like more clarification on. “I would love to see the legislation tackle that much more difficult but important issue of the level of evidence needed in order to support, for example, a class I determination for an accessory,” Thompson wrote.
He also suggested the new regulatory process would only be a modest improvement over what now exists. “[B]asically these new processes link to existing premarket notification and premarket approval pathways,” Thompson wrote. “They provide that if you can get FDA to agree to a particular classification of an accessory through those processes, then you can ask FDA to formally acknowledge it in a classification decision. That’s helpful. But I don’t know that it’s revolutionary. Right now, if FDA agrees to a classification through a premarket approval process, I don’t know that there’s any particular barrier to them setting up a new classification that they’ve already essentially acknowledged.”
But Thompson also criticized the current de novo process used for reclassifications. “At times the level of clinical evidence seems to rival that of a premarket approval application. But with a premarket approval application, the applicant gets exclusivity, at least in the sense that no one else can piggyback on their data. The opposite is true in a de novo submission, where basically then anyone can follow the pioneer with the new device through the new pathway that the pioneer has created. You’re basically tearing down the walls for the benefit of your competitor. Not many profit oriented businesses would be willing to do that,” Thompson wrote.