As reported by MedCityNews, at the annual AdvaMed conference, FDA commissioner Scott Gottlieb stated that it was time for Hill action on how LDTs are going to be regulated. Full article here.
Sound bite clipped below:
At the annual conference hosted by AdvaMed, the largest devices and diagnostics lobby on Tuesday in San Jose, Scott Gottlieb declared his intent to have Congress legislate how LDT’s operate.
“I will tell you where I am right now is that I believe having been around this issue and having tried to grapple with it …we are at a point where we need some kind of legislation,” Gottlieb told the audience. “I think there’s a better consensus among the various camps around this issue that we could potentially get legislative consensus and I think that the time is right to do that. I will fully admit that I am working very hard toward that goal.”
He added that he has been and will continue to talk to folks on Capitol Hill. “My view is that it would be a missed opportunity not to do it,” he said......
The "Official Prepared Remarks" are briefer on this topic and are posted at FDA (here). The remarks focused on FDA's approach to digital health, and that a novel "pre-certification" process was under active development for digital health software. Then, in the prepared remarks, Gottlieb was to remark that a similar "precertification" approach would be a good basis for a "the framework for a modern legislative approach" to LDTs.