Senators Circulate Plan For Standalone FDA Diagnostics Center, ‘In Vitro Clinical Test’ Rules
This article was originally published in The Gray Sheet
Senators are drafting legislation to create a standalone FDA Center to oversee diagnostics, including IVDs and LDTs, under a framework distinct from current medical device regulations.
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The clinical lab industry and IVD test-kit-makers appear ready to work with lawmakers on diagnostic reforms that would create a new category of regulated product for all lab tests that would undergo a mix of US FDA and CMS oversight. Meanwhile, key groups representing laboratory professionals remain fundamentally opposed to the concept.
Senate HELP Committee Chair Lamar Alexander, R-Tenn., suggested he would prefer to “start from scratch” in developing appropriate regulatory controls for laboratory-developed tests, despite a proposed regulatory framework for US FDA for the tests that was more than a decade in the making. That triggered some debate at a Sept. 20 committee hearing.
A House Subcommittee plans to take up draft legislation at a hearing next month that brings together test kits and lab-developed tests into a new regulatory category. The proposal offers many ways for tests to avoid a “high-risk” classification. “The Gray Sheet” compares the provisions to recent proposals vetted in the Senate.