May 2021: We've been hearing about a new era in laboratory test regulation since 2010, with multiple episodes (in one episode, FDA was going to take on national LDT regulation unilaterally).
The VALID Act amounts to reform of both packaged kit (IVD) test regulation and risk-based regulation of what have traditionally been LDTs. It was introduced in the prior Congress (March 2020; from 2020 see trade journal here, here, law firm Mintz Levin here; response of ACLA here). Favorable stance toward VALID from the Pew Foundation in January 2021, here.
Meanwhile, the smaller and feistier VITAL Act, from Sen. Rand Paul, would prohibit FDA regulation of LDTs. There's a pop-up of news on that front in May 2021.
VITAL 2021; AMP Support
May 18, 2021
See also something I missed a few weeks ago - on May 18, 2021, both AMP and the Association of Pathology Chairs (APC) weighed in with a press release supporting VITAL and urging its passage. "The VITAL Act of 2021 would enhance transparency, preserve innovation, and ensure widespread patient access to essential medical services." See 2-page PDF here.
|Support for Rand Paul's VITAL Act, Keeping FDA Away from LDTs|
Economics of VALID