In May, Rand Paul re-introduced his VITAL Act, which builds a wall around the FDA preventing it from regulating LDTs. AMP, Association of Pathology Chairs, and others voiced support - here.
On June 24, 2021, Burr, Bennet, DeGette, and Bucshon, representing both House and Senate and Republicans and Democrats, re-introduced the VALID Act, which would reform FDA regulation of both IVD's and LDTs to a considerable extent, while introducing risk-based FDA oversight of LDTs.
- Find the press release here.
- Find the plain-English six-age summary here.
- Find the legislative language here.
- The full act weighs in at 245 pages, 46,000 words.
- The 2020 version S3404 was only 38,000 words.