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Override: HHS Revokes FDA’s LDT Policies

 
• By Elizabeth Orr

The US department that oversees the FDA says the agency acted beyond its authority in asking labs to file emergency use authorizations, asserting that only CLIA rules should apply.

Pipette adding fluid to one of several test tubes

Creators of laboratory developed tests (LDTs) for COVID-19 don’t need to notify the US Food and Drug Administration before taking the diagnostics to market, the Department of Health and Human Services (HHS) said in a 19 August announcement.

The statement says the FDA won’t impose premarket review on LDTs absent the formal notice-and-comment rulemaking process. The requirement can’t...

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Dermal Fillers For Décolletage May Gain FDA Approval

 
• By Elizabeth Orr

An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.

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

 
• By Brian Bossetta

The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.

Finland Cracks Down On Software That Needs Regulating As A Medical Devices

 
• By Amanda Maxwell

Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it. 

Investors Urged To Prioritize Patient Engagement To Ensure Clients’ Products Succeed

 
• By Amanda Maxwell

To succeed in medtech, investors must focus on patient outcomes. Gilde Healthcare says involving patients boosts product effectiveness, access and market success — making it a smart strategy in today’s strained healthcare systems.

More from Policy & Regulation

Global Medtech Guidance Tracker: June 2025

 
• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

Finland Cracks Down On Software That Needs Regulating As A Medical Devices

 
• By Amanda Maxwell

Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it. 

Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations

 
• By Vibha Sharma

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.