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# Lab Tests Could be in Preparedness Bill
- URL: https://www.fdaweb.com/lab-tests-could-be-in-preparedness-bill/
- Published: 2023-04-05T12:00:00.000Z
- Updated: 2026-09-14T18:24:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154143

A *Roll Call* analysis of efforts to date to develop a pandemic preparedness reauthorization bill indicates that FDA oversight of laboratory-developed diagnostic tests is likely to be part of the debate. The [article](https://rollcall.com/2023/04/05/legislative-themes-emerge-on-upcoming-pandemic-reauthorization/?ref=fdaweb.com) says the effort to strengthen FDA oversight was dropped at the end of 2022 amid House procedural concerns and industry pushback on impacts on academic medical centers.

A standalone bill was [reintroduced](https://www.fdaweb.com/valid-act-reintroduced/) recently by Reps. **Larry Buschon** (R-IN) and **Diana DeGette** (D-CO). “What’s going to happen is, if we don’t do this legislatively, FDA is going to do something, right?” Buschon said. “And my preference always is to have a legislative process.”

FDA does plan to move forward, according to CDRH director **Jeffrey Shuren**. In a recent interview with the Alliance for a Stronger FDA, Shuren said, “We think it’s vitally important for spurring innovation and doing responsible innovation. New doesn’t matter if it really doesn’t work, or doesn’t work well.”

*Roll Call* says AdvaMed has lobbied for the increased agency oversight, which its diagnostics members already undergo. But the lab industry has signaled it could challenge FDA in court, the post says.