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Final Guidance Details FDA’s Summary Reporting Program

 
• By Elizabeth Orr

The VMSR program allows manufacturers of many low-risk devices to report adverse events on a quarterly basis. 

The US Food and Drug Administration has finalized a guidance document detailing a program that lets makers of eligible devices report some malfunctions in a summarized quarterly format.

Typically, device manufacturers are required to file Medical Device Reports (MDRs) every 30 days. But the Voluntary Malfunction Summary Reporting...

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

 
• By Amanda Maxwell

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EU Life Sciences Strategy Must Address ‘Regulatory Lasagna’

 
• By Amanda Maxwell

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FDA Publishes Final Cybersecurity Guidance To Replace Final Cybersecurity Guidance

 
• By Brian Bossetta

The US FDA has issued an updated final guidance document on cybersecurity considerations for medical device manufacturers that replaces a previous final guidance the agency issued in 2023.

New Regulation Significantly Expands eIFU Usage Scope

 
• By Amanda Maxwell

Amendment brings new benefits for device accessories and aesthetic devices used by healthcare professionals.

More from Policy & Regulation

Deaths And Serious Injuries Linked To A Pair Of Heart Device Recalls

 
• By Brian Bossetta

Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.

‘Be Quick, But Don’t Hurry’: Dexcom CEO Talks CGM Market Success

 
• By Marion Webb

Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.

June 2025: A Bumper Month For New EU Medtech Documents And Initiatives

 
• By Amanda Maxwell

The rate at which new documents to support the implementation of EU medtech regulations are issued has slowed of late; but June bucked the trend, with a flurry of activity.