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House Appropriators Will Tell US FDA 'Don't Finalize' LDT Guidance In 2018 Funding Bill

 
• By Sue Darcey

When the House Appropriations Committee takes up the US FDA funding bill for 2018, report language would "prevent the agency from finalizing a guidance on regulating laboratory developed tests," Rep. Rosa DeLauro said at a June 28 Ag/FDA subcommittee markup. The House bill, while maintaining FDA discretionary funding at its prior-year $2.8bn level, also fully appropriates user fee authorizations agreed to by Senate and House Committees in FDA Reauthorization bills in May and June, respectively.

A rider "that prevents FDA from finalizing guidance on laboratory-developed tests" will appear in report language for the House's FY 2018 FDA appropriations bill, Rep. Rosa DeLauro, D-Conn., said at a June 28 House Appropriations Committee, Agriculture and FDA subpanel markup. The rider follows FDA's decision in January to put off long-held plans to finalize a regulatory framework guidance for LDTs, leaving it up to Congress to figure out the best regulatory pathway for the diagnostic services.

DeLauro said she has "concerns" about the report language, which from her perspective, leaves LDTs "unregulated."

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• By Eileen Francis

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HealthAI: ‘Established Regulations Already Exist For Regulating AI In Healthcare Safely’

 
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Planning To Take Part in MDUFA? FDA Wants To Hear From You

 
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Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
• By Brian Bossetta

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

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