Deal Reached On FDA User Fee Renewal
Committee leaders in the US Congress have agreed on a stripped-down path to user fee reauthorization, which will not include FDA oversight of diagnostic tests.
You may also be interested in...
The VALID Act, which will hand diagnostics oversight to the US FDA, has been reintroduced in the House of Representatives after it failed twice last year in Congress.
Diverse voices across medtech are urging US lawmakers to include the VALID Act as part of the year-end omnibus package. Advocates say the legislation would create a uniform standard for diagnostics.
Passed by the US House and signed into law on 30 September, the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023, avoids a partial government shutdown and furloughs in FDA user-fee programs including MDUFA. Policy riders stripped from the legislation, including for FDA oversight of lab-developed tests, could still find their way into a final FY 2023 spending omnibus.