Lawmakers reintroduce diagnostic regulation bill that split the industry

Lawmakers have reintroduced draft legislation for a new regulatory framework for diagnostic tests, marking the third time a form of the proposal has been put to Congress.

 

The new version of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act hews closely to the draft introduced early in the pandemic. While there have been some changes, the focus is still on creating a risk-based regulatory framework specific to diagnostics and a new test product category — in vitro clinical tests, which includes lab-developed tests — while giving FDA authority to review and approve IVCTs.  

Source: https://www.medtechdive.com/news/lawmakers-reintroduce-diagnostic-regulation-bill-that-split-the-industry/602425/