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US Spending Bill Rider Looks To Stop Already Halted FDA LDT Guidance

 
• By Sue Darcey

A US FDA spending bill approved by the House Appropriations Committee July 12 would halt finalization of the agency's draft 2014 laboratory developed test guidance, recommending that FDA let Congress write its own bill directing any LDT regulation – but FDA already essentially handed the LDT reins to lawmakers last January.

House appropriators, as expected, have added a rider to 2018 FDA funding legislation directing that the agency suspend any efforts to finalize its laboratory-developed test guidance proposed Oct. 3, 2014 – but the agency already completely stopped work on its LDT guidance activities in January. (Also see "House Appropriators Will Tell US FDA 'Don't Finalize' LDT Guidance In 2018 Funding Bill" - Medtech Insight, 29 June, 2017.)

The Appropriations Committee passed an Agriculture/FDA funding bill July 12 that would give FDA a total of $2.8bn in discretionary funding for 2018 – essentially the same as the 2017...

More from Legislation

Debate On FDA User Fee Reauthorization Begins To Take Shape

 
• By Elizabeth Orr

A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.

Health Secretary Defends Spending Cuts During Senate Hearing On HHS Budget

 
• By Elizabeth Orr

Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.

Tariffs Threaten Medtech Innovation And US Position As World Leader, Whitaker Tells Lawmakers

 
• By Brian Bossetta

During his testimony before US senators on the impact of tariffs on critical supply chains, AdvaMed’s Scott Whitaker said the Trump tariffs could jeopardize America’s preeminence in medtech. Other industry experts echoed similar concerns.

‘The FDA Will Be Looking For Avenues To Regulate Laboratory Developed Tests’

 
• By Natasha Barrow

The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.

More from Policy & Regulation

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 
• By Amanda Maxwell

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 
• By Natasha Barrow

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.