On Eve Of House Hearing, FDA Makes Its Case For LDT Framework
This article was originally published in The Gray Sheet
The agency details 20 case studies to support its planned framework for regulating laboratory-developed tests in a report issued the day before a House subcommittee held a hearing on alternative legislative schemes.
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Lawmakers are circulating draft legislation that would create a new regulatory category, distinct from medical devices, combining in vitro diagnostics and laboratory-developed tests. The representatives say they don't have specific timing in mind for moving the bill forward. But it is being circulated just as the FDA user-fee reauthorization process is getting off the ground, presenting a possible legislative vehicle.
Following the agency's signal to stakeholders that it will not be finalizing a regulatory framework for laboratory-developed tests this year, industry experts suggest some other approaches FDA could take to address lab tests of all stripes.
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