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Device Makers To Get At Least Five Days Advance Notice For FDA Inspections: Guidance

 
• By Elizabeth Orr

A newly finalized FDA guidance on device firm inspection procedures recommends a five-day advance warning, three- to six-day inspections and lots of verbal communication throughout the process.

Big Important Day Date Reminder Circled Calendar 3d Illustration
• Source: Shutterstock

The COVID-19 pandemic has hit a temporary pause button on routine inspections of device firms by the US Food and Drug Administration. But background work on inspections continues, and that includes a new final guidance document offering guidelines on how the agency will conduct device establishment inspections.

The document, which was published 25 June, finalizes a draft guidance issued in March 2019. The FDA Reauthorization Act (FDARA) of 2017 mandated that the agency write the short six-page...

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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.