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Policy & Regulation

The Patient Perspective: Upcoming US FDA Device Center Studies Put Device-Users In Front Seat

A patient's point of view is paramount as the Center for Devices and Radiological Health embarks on a plan to conduct patient-perspective studies to ascertain what device-users want and value when it comes to health care. But don't call it a "survey" – "this is real research," CDRH compliance chief Robin Newman says.

FDA Medical Device Policy

MedTech Europe's John Brennan Moves On At Critical Time For Industry

After nearly nine years, MedTech Europe's John Brennan is leaving the medical device and diagnostics trade association. This is a particularly critical time for the industry body and its members, so what has tempted him away at this specific juncture?

Appointments Europe Regulation
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Regulation

Set Alert for Regulation

New Combination Product Registration Rules Coming To Malaysia

New guidance explains how Malaysia’s impending rules for registering combination products will work when they come into force in July 2018, and how much sponsors will have to pay to have their applications assessed.

Combination Products Review Pathway Malaysia

Latest From Regulation

Unapproved Indications Guidance Proves Controversial

FDA has collected more than 100 comments on a pair of draft guidance documents about manufacturer speech relating to unapproved devices or information not listed in device labeling. A document allowing manufacturers to disseminate some information not in the labeling drew fire from both sides, with patient groups worrying the change could pose a risk to the public, while trade groups saying the communication protections were still too narrow.

Advertising, Marketing & Sales Regulation

Webinar: What's Ahead For IVD Regulations In The EU And US

In this hour-long webinar, Medtech Insight's Amanda Maxwell and David Filmore, and In Vivo's Ashley Yeo discuss regulatory reforms in the works for in vitro diagnostics in the EU and US.

In Vitro Diagnostics Regulation

FDA Warning Letter Roundup & Recap – April 25, 2017

US FDA did not release any device-related warning letters the week of April 25.

Device Warning Letters Medical Device

Feds Holding Workshop on Medical Device Cybersecurity Gaps

Following several cases highlighting medical device cybersecurity vulnerabilities and concerns from experts and lawmakers about the federal government's response, FDA is joining with Homeland Security and the National Science Foundation to hold a two-day workshop to discuss potential gaps and how to fix them.

Regulation Safety

What's In the Official Journal Of The EU? Fake News?

A text has appeared in the Official Journal of the EU that is raising some questions over whether the new EU regulations are in the process of being officially published, an action which would trigger the countdown to them taking effect.

In Vitro Diagnostics Medical Device

AdComms To Meet On TransMedics Organ Transplant Device, Discuss '21st Century' Funds

Two US FDA advisory committee meetings are scheduled for May. One will delve into a new organ-transplant device intended to keep organs viable longer, while the other will present recommendations on how the agency should spend funds from the 21st Century Cures Act.

FDA Advisory Committees
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Quality Control

Set Alert for Quality Control

US FDA Device Center Pushes 'Total Product Life Cycle' Concept; 'Reorganization' Coming, Says Compliance Chief

The Center for Devices and Radiological Health is shaking up how its pre- and post-market specialists interact under a new "Total Product Life Cycle" scheme.

Life Cycle Management Quality Control Compliance

Latest From Quality Control

Snapshot: Device Recalls Tick Up Only 1% In 2016 Despite Midyear Surge

A count of fiscal year 2016 recalls provided by the agency shows that there were 43 high-risk class I (4%), 1,090 class II (92%) and 50 class III (4%) recalls last year, up a mere percentage point from the prior year. Device-makers had been on pace for a more modest number of corrections and removals for 2016, but a sudden mid-calendar-year spike in recalls caused the total to jump significantly.

Recalls Compliance

Medtronic StratMR Device Gets Class I Recall

Following a voluntary recall from Medtronic of its StratMR adjustable valves and shunts, US FDA has issued the highest level of recall for the devices, stating they could severely injure patients or cause death.

Recalls Safety

US FDA Warning Letter Scrutinizes Abbott Over Cybersecurity, Battery Lapses

FDA investigators are concerned Abbott's St. Jude Medical subsidiary failed to adequately address concerns over cybersecurity vulnerabilities and premature battery drain on their cardiac devices manufactured at its Sylmar, Calif., facility.

Regulation Compliance

Artificial Intelligence Center To Offer Quality, Regulatory Solutions

In this Medtech Insight podcast, Xavier University's Marla Philips explains why the school is teaming up with IBM Watson Health to launch a Center for Artificial Intelligence. "Our mission is to provide artificial intelligence solutions. We will have free and open access for anyone to use so they can implement those solutions across the pharma and device industries, and FDA itself," she says. Also: will AI steal human jobs?

Quality Quality Control

Mylan’s EpiPen Recall: Another Hit On The Auto-Injector

What began as an overseas recall of one lot made by a Pfizer subsidiary is expanding, threatening to besmirch Mylan’s once golden supply-chain quality record. The recall follows pricing controversy around the EpiPen product got the CEO hauled before Congress.

Safety Combination Products

House Subcommittee Grills Shuren On Facility Inspection Shortfalls

Members of the House Energy & Commerce Health Subcommittee probed FDA device-center chief Jeff Shuren about the agency's nascent efforts to improve facility inspections during a recent hearing on user-fee reauthorization. Lawmakers say they are hearing complaints from constituents about a lack of consistency and transparency in FDA inspection practices. Bills have now been introduced in both the House and Senate to address the issue, while FDA embarks on its "program alignment" upgrade to its inspections program.

Legislation Quality Control
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Policy

Set Alert for Policy

Latest From Policy

US FDA Still Waiting For Cures Money, Woodcock Says

When asked about Cures-related hiring, the FDA drug-center director says to her knowledge, no funding has been received yet.

FDA Policy

HHS Pressured By Lawmakers To Release Pandemic-Flu Plan

Two House Committee leaders are asking HHS Secretary Tom Price about the current status of an overdue pandemic influenza preparedness plan, including diagnostic advancements, that was promised last August. The lawmakers say they are worried about a US return of the H7N9 avian influenza virus, which re-emerged in China earlier this year.

In Vitro Diagnostics Infectious Diseases

Senate, House Panels Release Clean Device User-Fee Discussion Draft

Lawmakers emphasized the need for a swift reauthorization of a combined US FDA device and drug user-fee reauthorization bill before the end of July, and released a clean discussion draft April 14 that mirrors the agreements reached by industry and the agency last summer.

FDA Legislation

Device Week – April 14, 2017

On this week's Medtech Insight podcast: cybersecurity and US FDA warning letter headaches for St. Jude; a conversation with AdvaMed CEO Scott Whitaker; a profile of device-maker InVivo Therapeutics, which is looking to leverage 2tst Century Cures provisions; a verdict was reached in a Kimberly-Clark fraud suit; comments roll in on the Diagnostic Accuracy and Innovation Act in the US; and more.

Regulation Policy

Industry Confident About Device Tax Repeal, But It's Still Vehicle-Shopping

AdvaMed CEO Scott Whitaker says he is as confident as ever that permanent device tax repeal will happen this year. The only question is, he suggests, what legislative vehicle will bring it over the finish line. User-fee and children's health-insurance reauthorizations are options, along with tax reform, he says.

Legislation Policy

Industry Sees Much To Improve In Germany's New High-Risk Medtech Assessment Scheme

Only two of eight treatments passed muster under Germany's new NUBs scheme for assessing the benefit of high-risk products for inpatient use. As with the country's outpatient assessment counterpart, industry is pushing for changes.

Germany Health Technology Assessment
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