NEW YORK – The US Senate Committee of Health, Education, Labor and Pensions (HELP) on Tuesday released an updated version of the Verifying Accurate Leading-edge IVCT Development (VALID) Act attached to a larger legislative package that would reauthorize the Medical Device User Fee Amendments (MDUFA).
Legislators and observers have predicted that the MDUFA legislation could be a vehicle for passing the VALID Act, which would resolve decades-long questions around the US Food and Drug Administration's authority to regulate laboratory-developed tests by placing them within the agency's purview.
The VALID Act creates a risk-based framework for in vitro clinical test (IVCT) regulation, with high-risk tests, like novel assays, required to go through premarket review, while lower-risk tests could go to market after passing through technological certification. The law would grandfather in LDTs currently in clinical use.
MDUFA allows the FDA to charge companies fees for medical device reviews, with these fees making up almost half of the agency's annual budget. The current authorization will expire at the end of September 2022, meaning Congress will need this year to pass legislation reauthorizing the fees.
The VALID Act has drawn mixed reactions from the laboratory and diagnostics community, with stakeholders heavily invested in LDTs, like the American Association for Clinical Chemistry (AACC) opposed, and organizations on the IVD side of things, like the Advanced Medical Technology Association (AdvaMed), more supportive.
Following release of the updated version of the law, Susan Van Meter, president of the American Clinical Laboratory Association, said in a statement that the "release of the updated VALID Act, which aims to establish a diagnostics-specific regulatory framework for all diagnostic tests, represents a pivotal moment in the multi-year effort on diagnostic regulatory reform" and added that the organization and its members are reviewing the draft and plans to submit comments to the HELP Committee.