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Policy & Regulation

Set Alert for Policy & Regulation

Cybersecurity: Guidance Docs To Come, But Legacy Devices Still A Challenge

Increasing savvy around cybersecurity issues is driving regulators and trade groups to update their approach to the area, speakers from the US FDA and the American Medical Association said at this week’s FDA/CMS Summit.

Cybersecurity Regulation Guidance Documents

Tech Companies Grappling With A Brave New World Of Regulations While Developing Digital-Health Products

Software firms interested in the digital-health arena are engaging US FDA more and bolstering their regulatory credentials to navigate an unfamiliar regulatory landscape, industry experts tell Medtech Insight.

Digital Health Regulation Policy

Regulation

Set Alert for Regulation

Device Week, 6 December 2019 – Oh No, EtO!

Over the past year a number of medical device sterilization facilities that use ethylene oxide, or EtO, have shut down as state regulators have raised concerns about their potential environmental impact. On this week’s podcast, executive editor Shawn M. Schmitt chats with senior reporter Danny Al-Faruque about what’s happened to date, as well as where this EtO issue is headed in the future.

Device Week Safety Regulation

Latest From Regulation

Performance Criteria Issued On Magnetic Resonance Coils In New FDA Draft Guidance

Through a draft guidance, the US agency has established performance criteria for magnetic resonance coils, making the devices eligible for the standards-based Safety and Performance Based Pathway.

United States Medical Device

QUOTED. 6 December 2019. Jon Speer.

Medical device regulations that were set in place by the US FDA in the 1990s are evolving with the emergence of digital-health products and their iterative nature, medtech consultant Jon Speer says. Check out his comment here.

Quoted Digital Health

MDR/IVDR Corrigenda Due Final Sign Off Soon; Big Changes For Devices, Less So For IVDs

The European Parliament is about to sign off corrigenda to the Medical Devices and IVD Regulations. The headline news is a longer transition period for a huge swathe of class I products, but there are other changes too.

EU Europe

US Regulatory Roundup, November 2019: EtO Woes Concern Industry; FDA Pushes Back Deadline For Blended QSR/ISO 13485 Rule; And More

Concerns expressed by stakeholders during a two-day FDA meeting on the use of ethylene oxide (EtO) to sterilize medical devices was of most interest our online readers last month. EtO was also the focus of several other highly read stories – including worries by industry about device shortages and news that device maker Teleflex expects to lose millions because an EtO facility shut down. Meanwhile, the FDA’s announcement that it would push back its deadline for delivering a draft version of a new rule that will harmonize its Quality System Regulation with ISO 13485 also garnered significant interest. Here are November’s 10 most popular US regulation and policy stories from Medtech Insight.

United States Regulation

Global Medtech Guidance Tracker: November 2019

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-eight guidance documents have been posted on the tracker since its last update.

International India

Warning Letter Roundup & Recap – 3 December 2019

In the only device-related warning letter released by the US FDA this week, a manufacturer of surgical trays and kits was cited for quality systems violations.

Device Warning Letters FDA
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Quality Control & Compliance

Set Alert for Quality Control

Analyzing Quality Data Is Essential. Here’s What One Expert Says Your Firm Should Do To Stay In FDA’s Good Graces

Device makers should make sure they have adequate resources to analyze quality data they take in so they can prevent the recurrence of nonconforming products, processes and procedures. That’s just one nugget of advice from former FDA investigations branch director Ricki Chase, who explains why collecting and properly handling such data is critical to complying with agency expectations in this Medtech Insight Q&A interview.

Quality FDA Compliance

Latest From Quality Control

Warning Letter Roundup & Recap – 3 December 2019

In the only device-related warning letter released by the US FDA this week, a manufacturer of surgical trays and kits was cited for quality systems violations.

Device Warning Letters FDA

Warning Letter Close-Outs – November 2019

The US FDA released one device-related close-out letter in November.

Device Warning Letters FDA

How Your Medtech Company Can Build Trust With FDA Investigators – And The Agency At Large

Device makers that build bridges with US FDA investigators will have an easier go of things during facility inspections, says Ricki Chase, a former FDA investigations branch director. By doing this, firms can extend that trust to the agency as a whole. Check out our full Q&A with Chase here.

FDA Compliance

Medtronic Warns On Insulin Pump Safety

Medtronic has announced a safety issue in its popular MiniMed 600 series of insulin pumps. The devices may under- or over-deliver insulin if a ring component of the device cracks or breaks, potentially causing serious health issues. The company says the issue doesn’t amount to a recall, however.

Quality Control Safety

Delayed Twice, FDA Now Says It Won’t Release Its Harmonized QSR/ISO 13485 Draft Rule Until April 2020

First it was April 2019, then September 2019 – but both of those deadlines were missed. Now, the US agency has set a target date of April 2020 to release a draft regulation that will harmonize its Quality System Regulation (QSR) with international standard ISO 13485.

Regulation Standards

Close-Out Meetings With FDA Investigators: What Manufacturers Need To Know Before Their Next Inspection

When the US agency comes to inspect a manufacturer’s facility, one of the more important activities that occur is a close-out meeting. Consultant and former FDA investigations branch director Ricki Chase explains why these meetings, held daily or at the end of an audit – or both – can help make or break an inspection.

Compliance FDA
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Policy

Set Alert for Policy

Latest From Policy

QUOTED. 6 December 2019. Jon Speer.

Medical device regulations that were set in place by the US FDA in the 1990s are evolving with the emergence of digital-health products and their iterative nature, medtech consultant Jon Speer says. Check out his comment here.

Quoted Digital Health

MDR/IVDR Corrigenda Due Final Sign Off Soon; Big Changes For Devices, Less So For IVDs

The European Parliament is about to sign off corrigenda to the Medical Devices and IVD Regulations. The headline news is a longer transition period for a huge swathe of class I products, but there are other changes too.

EU Europe

US Regulatory Roundup, November 2019: EtO Woes Concern Industry; FDA Pushes Back Deadline For Blended QSR/ISO 13485 Rule; And More

Concerns expressed by stakeholders during a two-day FDA meeting on the use of ethylene oxide (EtO) to sterilize medical devices was of most interest our online readers last month. EtO was also the focus of several other highly read stories – including worries by industry about device shortages and news that device maker Teleflex expects to lose millions because an EtO facility shut down. Meanwhile, the FDA’s announcement that it would push back its deadline for delivering a draft version of a new rule that will harmonize its Quality System Regulation with ISO 13485 also garnered significant interest. Here are November’s 10 most popular US regulation and policy stories from Medtech Insight.

United States Regulation

Competent Authorities Drive Unilateral Eudamed Delay Decision Onto Council Of EU Agenda

The two-year delay to Eudamed was a Commission decision. Now the competent authorities are fighting back and the issue is to be discussed at the level of the Council of the European Union on December 9 to avoid “heavily burdensome administrative transitional solutions.”

Medical Device Europe

EU Regulatory Roundup, November 2019: Big Changes For Medtech Regs Implementation

With six months left to the full implementation of the EU’s Medical Devices Regulation, there are a couple of big shifts taking place in the way it is being applied. Following news of the Eudamed database two-year delay, confirmation looks imminent that many more products will avoid having to comply with the MDR by next May. But will this plan sufficiently alleviate implementation pressures?

Europe Blocs

Eudamed Timelines: Unraveling Contradictory Legislation To Understand How The Deadlines Apply – A Lawyer’s View

The new version of the Eudamed database has been delayed – the European Commission says by two years. But how extensive is the delay? Fieldfisher partner, Alison Dennis, explains why the medtech sector needs to be cautious about how it interprets the latest developments.

Europe EU
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