VALID Act Re-Introduced in House of Representatives

Representatives Larry Bucshon (R-IN) and Diana DeGette (D-CO) recently reintroduced the Verifying Accurate, Leading-edge IVCT Development (VALID) Act in the House of Representatives. Like previous versions of this legislation, the VALID Act seeks to revamp the FDA’s oversight of in vitro diagnostics (IVDs) and establish a new category of in vitro clinical tests (IVCTs) that encompasses both laboratory-developed tests (LDTs) and IVDs, which would be regulated by the FDA. The legislation would provide the FDA with far-reaching oversight over laboratory-developed tests (LDTs) and impose new regulatory requirements on laboratories that develop and use LDTs. NILA is currently reviewing the newly introduced legislation as it compares to the last version of the bill and will provide comments to Congressional sponsors on behalf of NILA.

The VALID Act has not yet been reintroduced in the Senate. The former Republican sponsor of the bill, Senator Richard Burr (R-AL), retired at the end of 2022. The bill may not be reintroduced in the Senate until another Republican Senator is identified to replace Senator Burr in leading the VALID Act.