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From Electronic Docs To FOIA Requests, FDA Lays Bare Its Process For Remote Regulatory Assessments

 
• By Shawn M. Schmitt

A document from the US FDA obtained by Medtech Insight advises medical device manufacturers on how a voluntary Remote Regulatory Assessment will unfold. RRAs are being conducted by the agency in lieu of on-site facility inspections because of the COVID-19 pandemic.

FDA building.

Device makers that agree to a Remote Regulatory Assessment by the US Food and Drug Administration are presented with a three-page explainer of how the agency plans to perform the RRA.

The FDA’s document, sent to a Florida device firm and obtained by Medtech Insight, advises manufacturers on how best...

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MHRA Opens Second AI Airlock Program For Applications

 
• By Natasha Barrow

"The AI Airlock program creates a supervised testing ground where novel technologies and challenge areas can be safely investigated," said James Pound, MHRA interim executive director of innovation and compliance.

MHRA’s Tallon Hails PMS Regulation As Start Of UK Device Framework Transformation

 
• By Ashley Yeo

16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
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UK Healthtech Center Of Excellence Given Key MHRA Digital Regulation Role

 
• By Ashley Yeo

Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.

More from Policy & Regulation

EU Pilot Features ‘All-In-One’ Regulatory Path For Drug/Diagnostic Trials

 
• By Vibha Sharma

The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.

European Medtechs Reiterate Opposition To Reciprocal Tariffs On US Imports

 
• By Ashley Yeo

EU countermeasures against US tariffs suggest medtech categories exported to the EU could be targeted for tariffs. MedTech Europe and the German IVDs industry have stressed the negative effects this would have on patient care.

Innovative Wants Injunction Against J&J Subsidiary After $442M Antitrust Verdict

 
• By Elizabeth Orr

Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.