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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Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.

HHS Suggests Drastic Reductions To Skin Substitute Payments

 
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The US Department of Health and Human Services has proposed cutting Medicare reimbursement for skin substitutes used in chronic wound care by up to 90%. The change aims to address rising costs but could harm patient access and treatment quality, prompting concerns from industry stakeholders.

International Reliance Gets UK MHRA OK In Drive For Agile Pre-Market Regulation – CE Marking Next

 
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The UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.

Expert Panels Remain Tough On Manufacturers And Their Notified Bodies

 

The EU’s extra layer of checks on clinical evidence is proving a difficult, and sometimes humiliating process, for many device companies whose products have come under the spotlight.

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Injuries And Deaths Linked To Baxter Infusion Pump

 

The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.

Bates To Energize UK Office For Life Sciences

 
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Steve Bates, head of the UK BioIndustry Association, has been appointed executive chair of the government’s Office for Life Sciences as the UK restructures its life sciences approach and drives health outcomes with a new NHS Long-Term Care plan.

International Reliance Gets UK MHRA OK In Drive For Agile Pre-Market Regulation – CE Marking Next

 
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The UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.