ARTICLE SUMMARY:
In this week’s roundup: The US Senate unveils its draft FDA user fee bill, including comprehensive VALID Act reforms to regulation of diagnostics, while the House moves its user fee bill out of committee. EU regulatory updates including MedTech Europe preps for the IVD Regulations, more progress on standards recognition, and more MDR bottleneck data from notified bodies. Also, Google taps Bakul Patel, GAO looks at FDA COVID test efforts, and more global medtech policy updates.
Capitol Hill Picks
Diagnostics reforms and more hitch on to FDA reauthorization efforts:
Senate picks up diagnostics reform. The prospects of comprehensive reform to FDA regulation of diagnostics increased this week when Senators included it in an FDA user fee reauthorization discussion draft. Specifically, the draft user fee bill, unveiled May 17, includes an updated version of the VALID Act, which was previously introduced in Congress to create a new FDA-regulated product category called In Vitro Clinical Tests (IVCTs), combining IVD test kits and lab-developed test (LDT) services. VALID would establish a distinct oversight framework for IVCTs that shares elements with the medical device framework, but with key differences—including “analytical and clinical validity” serving as the underlying standard for approval rather than “safety and effectiveness.” (See “Reform in the Time of Coronavirus? Diagnostics Bill Surfaces as Pandemic Escalates,” Market Pathways, March 24, 2020.)
