Pew Comments on Discussion Draft of VALID Act to Update In Vitro Diagnostics Regulations

In February 2019, The Pew Charitable Trusts offered comments on the discussion draft of the Verifying Accurate Leading-edge IVCT Development (VALID) Act, a bill that would update how diagnostic tests involving human samples, known as in vitro diagnostics (IVDs), are regulated. IVDs play an important role in health care, with providers and patients relying on them to provide accurate information to inform their decisions. But as technology has advanced and the way providers use diagnostic tests has evolved, the oversight scheme for them has not kept up. Though many details have yet to be resolved, the VALID Act draft represents an important step in the broader effort to reform this outdated system. This act reflects a set of principles that Pew believes should be part of any updates to IVD regulations, in order to ensure patient safety while enabling innovative tests to come to market expeditiously.