FDA has Regulatory Options for LDTs Even Without Final Guidance

Manufacturers should probably expect some regulation of laboratory-developed tests (LDTs) next year, even though the FDA has said it will not finalize its draft LDT guidance, said attorney Jeffrey Gibbs, of Hyman, Phelps & McNamara P.C.

“While many in the lab community have been praising the announcement from FDA, in our view, this fight may not be over,” he said. “It may now shift from a battle over sweeping guidelines to case-by-case challenges using ill-defined criteria.”

The FDA announced that it will not release final guidance on LDTs, and instead will work with Congress and other stakeholders to determine how LDTs should be regulated. Although it is unclear exactly what form these regulations will take, there are a number of possibilities.