THREAD: Today, Congress introduced the VALID Act of 2020, a bipartisan effort to modernize clinical testing by giving #FDA flexible new authorities that balance safety and innovation. Some thoughts on this important step 1/n 
This bill would create new regulatory pathways that are specifically tailored for diagnostic testing. It would improve our ability to detect disease and select the right treatments for patients 2/n
VALID includes creative flexible approaches to help FDA efficiently review today’s rapidly changing technology. The new “technology certification” process would significantly streamline submission/review requirements for technologies used to develop many different clinical tests
Clinical tests increasingly incorporate advanced software to generate accurate results. VALID makes FDA review of modifications more efficient, focuses on changes affecting analytical or clinical validity, but not requiring review of updates that don’t have adverse effect on test
To make sure the U.S. has access to needed testing in a public health emergency, under VALID labs can develop tests and then notify HHS, similar to the EUA approach recently announced by FDA, but with changes to the timing and submission requirements for labs.
FDA's medical device center @FDAcdrhIndustry (CDRH), led by Jeff Shuren, and reflected again yesterday in remarks by Elizabeth Hillebrenner, has long committed to working with Congress and stakeholders to help ensure access to reliable diagnostics that promote public health. 6/n
This bill was developed with extensive input from dedicated staff @US_FDA, broad stakeholder engagement including IVD manufacturers, labs, patient groups, and professional organizations, working with the offices of @SenatorBurr @SenatorBennet @RepDianaDeGette @RepLarryBucshon 7/n
