FDA rolls out long-awaited proposal to overhaul diagnostics regulation
September 29, 2023 — Brett Meeks, Executive Director of LAB, spoke with Endpoints News about the newly released FDA proposed rule to regulate Laboratory Developed Tests (LDTs) and stated the rule could open FDA up to litigation from groups who say the agency does not have the authority to do this on its own.
“Most of the proposed rule actually reads like a legal brief where FDA is justifying its authority,” he said. “There are a lot of citations to case law, saying that FDA has the authority to regulate in this space, and just because of the way the proposed rule is set up like that, it really goes to show that I think FDA is aware that they may not have this authority. ”