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Video of Congressional Hearing on LDTs Posted Online; FDA Defends Regulatory Authority

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The video coverage of the September 9 House Energy and Commerce Health Subcommittee hearing regarding the FDA’s intention to issue draft guidance on laboratory-developed tests has been posted online t house.gov.

Among key discussion points was FDA’s authority to regulate LDTs.

Rep. Michael C. Burgess (R-Texas) and other Republicans asked Jeffrey Shuren, director of the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), if FDA was able to bypass the formal rulemaking process. Shuren defended FDA’s authority in this regard, and also stated that the draft guidance would be released within 30 days.