VALID Act Still a Priority for FDA

The overhauling of the FDA’s oversight of in vitro diagnostics will see significant movement in 2023, according to Andi Fristedt, the agency’s deputy commissioner for policy, legislation and international affairs.

The effort, which the FDA and industry collaborated on during 2021 and 2022, had been attached to the user fee reauthorization bill but was left on the cutting room floor with many other riders and amendments when Congress greenlighted a “clean” version of user fee legislation in September — and again in December when lawmakers attached many of those riders and amendments to the omnibus bill and passed it.

“Those priorities that we didn't see advance will remain important priorities for the agency,” Fristedt said, in a Jan. 13 webinar hosted by the Alliance for a Stronger FDA.

The Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which did not make it into the omnibus funding bill, could reemerge soon, she said. The act would give the FDA regulatory oversight of laboratory developed tests currently overseen by the Centers for Medicare & Medicaid Services (CMS) and would create a new category — in vitro clinical test.