FDA User Fee Bill to Include Diagnostics Changes, Murray Says

Legislation that would reform how diagnostic tests are regulated will be part of the FDA’s must-pass user fee bills, Sen. Patty Murray (D-Wash.) confirmed Tuesday, a move that could settle a longstanding debate about the agency’s authority over laboratory-developed tests.

“Senator [Richard] Burr and I are working on a bipartisan policy to try and improve the regulation of laboratory-developed tests,” Murray said while presiding over the Senate Health Education Labor and Pension Committee’s pandemic preparedness hearing. Lab-developed tests are those that are designed, manufactured, and used in a single laboratory.

She said they aim to include the measure in ...