US Regulatory Roundup, 2018: 5 Core Issues That Help Explain The Year In Medtech Policy

Global harmonization, regulatory innovation, rising safety scrutiny, medtech reimbursement hopes and global trade threats were key underlying concepts for the medtech regulatory and policy environment in 2018. Here's a spotlight on those issues and the top 30 articles from last year.

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Although 2018 ended with a government shutdown, for most of the year, new proposals and programs flowed out of Scott Gottlieb's US FDA at a mile-a-minute. It remains to be seen what elements of the agenda will end up as lasting components of US device regulation, but there is no question that the past year has been a period of regulatory innovation, with multiple pilots picking up speed, major reforms announced, and restructurings pursued.

Much of FDA's recent reform plans have been framed as paths to streamlining regulations and supporting the US as a...

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

 

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

 

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.

EU Life Sciences Strategy Must Address ‘Regulatory Lasagna’

 

MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”

FDA Publishes Final Cybersecurity Guidance To Replace Final Cybersecurity Guidance

 

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.

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Former Top OIG Attorney Gives Inside Look At Fraud Prevention

 
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Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.

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

 

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

 
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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.