By Ann H. Carlson
If enacted by Congress, the bipartisan VALID Act would implement a risk-based review system for all diagnostic tests, including laboratory-developed tests, under the U.S. Food and Drug Administration (FDA).
Title: Verifying Accurate Leading-edge IVCT Development (VALID) Act
House bill (HR 4128): Rep. Diana DeGette (D-Colo), Rep. Larry Bucshon (R-Ind)
Senate bill (S.2209): Sen. Richard Burr (R-NC), Sen. Michael F. Bennett (D-Colo), Sen. Mike Braun (R-Ind)
Notable Proponents: AdvaMed, Pew Charitable Trusts
Notable Opponents: American Association for Clinical Chemistry (AACC), Coalition for Innovative Laboratory Testing
- Brings LDTs under FDA oversight.
- Creates a separate regulatory category called “in vitro clinical tests” (IVCTs), which includes all in vitro diagnostics (IVDs) and LDTs.
- Develops a three-tiered risk categorization system for all IVCTs:
- High-risk tests (those that could lead to harm or death with a false result), which will be subject to premarket review.
- Moderate-risk tests, which developers can submit for review through a voluntary “technology certification program;” once approved, no FDA review will be required for tweaks to these tests after they are on the market.
- Low-risk tests, which will be exempt from premarket review.
- Creates registration requirements for grandfathered/low-risk tests.
- Details post-market surveillance obligations.
- Establishes a program to expedite the development of IVCTs that address unmet needs for patients.
- Includes user fee process provisions that allow the FDA and the industry to “negotiate user fees for IVCTs just as they do for other medical products,” per Akin Gump7.
Next steps: The VALID Act will likely undergo many revisions before coming up for a vote—and it could be scrapped altogether. However, according to The National Law Review, the fact that the VALID Act is part of the Senate HELP MDUFA bill increases the likelihood that the bill will pass in some form1, 2.
Ann H. Carlson is a regular contributor to CLP.
- “The VALID Act: Senate Action Brings FDA Regulation of LDTs Closer to Fruition.” Bolani, James A. and Robertson, Megan. The National Law Review. May 20, 2022. www.natlawreview.com/article/valid-act-senate-action-brings-fda-regulation-ldts-closer-to-fruition
- FDASLA Act of 2022. U.S. Senate Committee on Health, Education, Labor & Pensions. Undated. https://www.help.senate.gov/imo/media/doc/FDASLA%20Discussion%20Draft%20May%2017%202022.pdf