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Policy & Regulation

Set Alert for Policy & Regulation

Reimbursement A Top Goal For New Digital Health Lobbying Center

As digital health becomes more ubiquitous in the medical device space, industry advocacy group AdvaMed has launched a Center for Digital Health to aggregate its resources and coordinate efforts to lobby the government on behalf of digital-health companies.

Regulation Policy Lobbying

EU Or US First Choice For Launching Innovative Products? What You Really Need To Know

The tightening of the EU regulatory system will increase timelines for the availability of devices, especially novel, high-risk devices. But those who believe the US system will be quicker should not be so eager to jump to conclusions. Clinical data expert Sarah Sorrel explains why.

Medical Device Europe North America


Set Alert for Regulation

Self-Care Devices May See Extension After EU Commission Admits MDR ‘Inconsistencies’

Self-care medical devices may be included in the four-year “grace period” following implementation of the new EU Medical Device Regulation as part of an incoming corrigendum to the law, a spokesperson for the European Commission suggested at a recent AESGP meeting.

OTC Devices Regulation Europe

Latest From Regulation

Warning Letter Roundup & Recap – 22 October 2019

No device-related warning letters were released by the US FDA the week of 22 October.

Device Warning Letters FDA

EU MDR: Medtechs Must Look At The Bigger Picture Of Regulatory Compliance

The EU MDR represents the biggest collective change in many years for medtech companies in terms of how they prepare their approach to market. With time running short for companies’ preparations ahead of the regulation’s implementation date of 26 May next year, the UK ABHI’s final pre-MDR regulatory conference in late October will be both a check list for companies en route to compliance and a debate about the wider role of risk in regulatory compliance.

EU Medical Device

China Joins International Post-Market Surveillance Program

China’s National Medical Products Administration says that participating in the International Medical Device Regulators Forum’s program will help it control the risks associated with imported products.

China Safety

QUOTED. 21 October 2019. Zach Rothstein.

AdvaMed has launched a Center for Digital Health to aggregate its resources and coordinate efforts to lobby the government on behalf of digital-health companies, among others on how to pay for new digital-health products. See what Zach Rothstein, AdvaMed's VP for technology and regulatory affairs, said about it here.

Regulation Lobbying

QUOTED. 18 October 2019. CJ Porter.

New Orleans-based UTC Laboratories agreed to pay $41.6m to resolve alleged violations of the False Claims Act, the US Department of Justice (DOJ) announced recently. See what CJ Porter, special agent in charge with the Department of Health and Human Service Office of the Inspector General, said about it here.

Quoted Enforcement

Personalized Medicine Firm Pays $42M On Kickback Allegations Tied To Genetic-Testing Registry

Louisiana-based pharmacogenetic testing company UTC Laboratories and its three principals have agreed to pay $42.6m to resolve allegations that the company violated the False Claims Act by paying kickbacks for referrals and providing tests that were not medically necessary.

Diagnostics Enforcement
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Quality Control & Compliance

Set Alert for Quality Control

Compliance Corner: Cybersecurity Patches Aren't Recall Events – But A New 510(k) May Be Needed Over Time, Expert Says

Eric Henry with the law firm King & Spalding says that while software cybersecurity patches typically don't rise to the level of a recall, device-makers should still consider the cumulative effect of software changes on products.

Compliance Corner Cybersecurity Recalls

Latest From Quality Control

Warning Letter Roundup & Recap – 15 October 2019

In the only device-related warning letter released by the US FDA this week, a manufacturer of a dental X-ray sensor and X-ray system was cited for quality systems violations. The firm also failed to notify the agency of accidental radiation occurrences.

Device Warning Letters FDA

Device Week, 11 October 2019 – Total Recall: The Latest On Corrections & Removals

On this week’s podcast, executive editor Shawn M. Schmitt and senior reporter Elizabeth Orr delve into recent news on medical device recalls, including tips and advice from US FDA officials, and a report about a new app that scans products and gives detailed safety and recall information.

Device Week Recalls

Compliance Corner: FDA Officials Share Tips To Ensure A Smooth Recall

Officials in the US FDA's recall divisions advised manufacturers on the best ways to work with the agency during the recalls process, including keeping track of who they're speaking with, making sure all required forms are complete, and not being afraid to use eSubmit.

Compliance Corner Recalls

'SoomSafety': How A Real-Life Recall Scare Led A Father To Develop A Free App That Gives Detailed Device Safety Info

When Charlie Kim and his family was taking care of their sick child Isabella inside their home, tragedy struck. A tracheostomy tube that Isabella depended on to keep her alive failed, leading to complications. Later, Kim wanted to get to the bottom of what happened and was shocked to discover that Isabella's tube had been recalled. "I was thinking, 'Wait – how did we get this if it's on recall?'" he said. That's when Kim became an advocate for patient safety by launching a company called Soom that developed a software platform to help device-makers iron the kinks out of their distribution chains. But beyond that platform, Soom developed the SoomSafety app, which allows users to scan device barcodes to get up-to-date information about the products, including whether they're subject to an ongoing recall.

Recalls Safety

US Regulatory Roundup, September 2019: QSR/ISO 13485 Mash-Up, FDA Commissioner News, New Guidance Docs, And More

The latest news on the FDA's work to harmonize its Quality System Regulation with international quality systems standard ISO 13485 captured the attention of many of our online readers last month, as did stories about an upcoming pick by President Trump to fill the agency's top spot as commissioner and a slew of new, draft and updated guidance documents. Here are September's 10 most popular US regulation and policy stories from Medtech Insight.

United States Quality Control

QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year's End

All signs point to the US agency exercising enforcement discretion for device-makers when it rolls out a new final rule that merges the Quality System Regulation with international standard ISO 13485. "We'll give companies time on the transition," FDA device center chief Jeff Shuren said at the MedTech Conference on 25 September. Meanwhile, an industry insider tells Medtech Insight that a draft of the regulation probably won't be out until the end of the year because of "disagreements technically on the inside" of the agency.

Regulation Standards
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Set Alert for Policy

Latest From Policy

Senators Want Answers From FDA Soon On Device Servicing Versus Remanufacturing

US Senators Elizabeth Warren and Bill Cassidy recently sent a letter to FDA acting commissioner Ned Sharpless prodding him to provide them details by 1 November on how the agency plans to regulate medical device servicers that may actually be remanufacturing devices.

Policy Life Cycle Management

QUOTED. 21 October 2019. Zach Rothstein.

AdvaMed has launched a Center for Digital Health to aggregate its resources and coordinate efforts to lobby the government on behalf of digital-health companies, among others on how to pay for new digital-health products. See what Zach Rothstein, AdvaMed's VP for technology and regulatory affairs, said about it here.

Regulation Lobbying

US House Panel Advances Bill Allowing Medicare Coverage Of Eyeglasses, Hearing Aids, Dental Services

Bills permitting Medicare coverage of eyeglasses, hearing aids, dental implants and the exams needed for prescriptions for these medical products were approved by the US House Energy and Commerce Committee on 17 October, and passed onto the full House for its consideration.

Policy Legislation

Graeme Tunbridge To Lead MHRA Devices Unit During Interim, Reports Indicate

Today is John Wilkinson’s last day as head of devices at the UK’s MHRA. It looks like his successor will be someone who can ably assist in the transition ahead, as the UK copes with upcoming Brexit arrangements and the EU attempts to successfully implement the new Medical Device and IVD Regulations.

Medical Device Europe

Precision Medicine Bill Sponsored By Democrat Eric Swalwell Gains Support In US House

A bill that would promote genetic testing for infants and children, introduced by California Rep. Eric Swallwell, is gaining support in the US House of Representatives.

Policy Legislation

German Patient Data Shows No Paclitaxel Mortality Risk

A review of German insurance data found no additional risk of death in patients treated with drug-coated balloons and stents, even in patients who had the devices for more than a decade. The data appears to further challenge a bombshell meta-analysis that claimed paclitaxel could increase death rates by up to 90%.

Germany Medical Device
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