Kyle Faget Comments on FDA Approach to Laboratory Developed Tests

Foley & Lardner LLP partner Kyle Faget is quoted in the MD+DI article, “Medtech Is Missing the Forest for the Trees in the LDT Debate – But So Is FDA,” commenting on the U.S. Food and Drug Administration’s approach to laboratory developed tests (LDTs).

“Some of the critics have pointed out that for infectious disease that can have local impact, for example, sometimes it’s really important to have that local testing capability and efficient testing capability,” said Faget, who is co-chair of Foley’s Health Care Practice. She noted though that LDTs are being used today to diagnose and guide treatment decisions for things like cancer, rather than a locally focused infectious disease.

“In some ways, the FDA would have been wise to defer to the VALID Act, which would have been a congressional movement towards clarifying…because some people out there are criticizing FDA saying, “Have you overreached? Is this really in your domain?’ And if Congress had acted under the VALID Act, which they still might, it would be very clear FDA can act here,” Faget continued.

When asked to compare the FDA’s regulatory action on LDTs to its approach to artificial intelligence, Faget said, “I think when something is new to the market, FDA is pretty committed to taking a risk-based approach to regulation. So, in the context of AI, if they’re low-risk products than FDA isn’t going to regulate. I think it’s similar here. LDT’s when thought of as being lower risk and add-on that there is another regulatory body that provided oversight. I think FDA thought, ‘Hey, that’s good enough,’ and then the pandemic showed evidence otherwise.”