Don’t Fast-track FDA In Vitro Diagnostics/Lab-Developed Tests Oversight Bill: ASCP

ASCP, the American Medical Association, and 17 other organizations submitted a letter to congressional leaders to discourage them from fast-tracking legislation to revamp federal oversight of laboratory developed tests (LDTs).

One of the “must pass” bills for 2022 is the reauthorization of the Medical Device User Fee Amendments (MDUFA), which specifies the fees paid by companies seeking FDA approval for medical devices and laboratory tests. Some proponents of the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, which would drastically change the way LDTs and commercial In vitro devices are regulated, have been urging Congress to attach that bill to the MDUFA legislation to fast-track its approval. The measure would require many LDTs to undergo review and approval by FDA.

ASCP and other co-signers urged Congress not to adopt a fast track approval of the bill. Instead, we urged Congress to review this legislation independently of other legislation so that it can thoughtfully and carefully consider the bill’s provisions. The letter argued that the VALID Act is highly complex and represents a significant change in device oversight, both for in vitro diagnostics and LDTS, and that separate consideration is in the best interest of quality patient care and public health. ASCP will be monitoring the VALID Act during the remainder of this legislative session.