Medical Devices

News & Analysis as of

Medical Device Alert – Finalised texts of the new EU Regulations on medical devices and in-vitro diagnostic medical devices are...

On 22 February 2017, the Council of the European Union issued the final versions of the draft texts of the European Union (“EU”) Medical Device Regulations (“MDR”) and the In Vitro Diagnostics Regulation (“IVDR”)....more

Ethicon To Acquire Torax Medical, Inc

Ethicon Inc. announced on February 17 that it reached an agreement to acquire Torax Medical, Inc. According to its website, Torax Medical is a privately held medical device company developing a minimally invasive surgical...more

Regulate Frankenstein: the European Parliament calls for new rules for robots

When a parliamentary report cites Mary Shelley’s Frankenstein in its recitals and proposes new regulation for robots with artificial intelligence (“AI”), one cannot be sure whether the 19th or the 21st century has inspired...more

Northern District of Illinois Strikes TCPA Class Allegations

Earlier this month, the Northern District of Illinois struck the class allegations in Cholly v. Uptain Group, Inc., a single-count TCPA case filed against a medical services provider and a debt collector based on allegedly...more

Expanding Duties and Eroding Protections for Medical Device Manufacturers

Earlier this month, the Washington Supreme Court saddled medical device manufacturers with a new duty to warn under Washington law—the duty to warn hospitals about potential risks their products may pose—and eroded exemptions...more

FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

Advocating for Patient Safety: Coalition for Patient Vision Care Safety submits comments in response to FTC Proposed Rule...

The Coalition for Patient Vision Care Safety (“Coalition”) is a group of health care providers, medical device manufacturers and academic institutions dedicated to ensuring the safe and appropriate use of contact lens so that...more

AGG Food and Drug Newsletter - February 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Alert: 2016 Round-Up: Key Decisions Affecting Connecticut Health Care Providers

Connecticut state and federal courts faced a number of significant health care issues last year. We have summarized those cases that we think are particularly relevant to Connecticut hospitals, group practices and individual...more

International Product Liability Review - Issue 65

The International Product Liability Review provides quality updates and comment from around the world on legal developments in the field of product liability and product safety. Please see full Publication below for more...more

CFDA Amends Medical Device Recall Rules

Recently China’s Food and Drug Administration (“CFDA”) released the Provisions for Medical Device Recall (“New Recall Rules”). The New Recall Rules, becoming effective on May 1, 2017, will replace the existing Interim...more

FDA Devices Center Issues Multiple Guidances in the Obama Administration’s Final Months

A flurry of regulatory activity preceded the transition in administration on January 20. Anticipating that the new administration would impose a regulatory slowdown, the Food and Drug Administration’s (FDA’s or the...more

FDA 2016 Year in Review

The enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform...more

St. Jude Cybersecurity Vulnerability Extended to Provider-Owned Devices

Earlier this week, the U.S. Department of Homeland Security (DHS) updated a prior advisory revealing cybersecurity vulnerabilities in St. Jude Medical’s Merlin@home transmitter....more

After the Fact: FDA’s Guidance on Postmarket Management of Cybersecurity in Medical Devices

The Food and Drug Administration (FDA) recently issued nonbinding guidance focusing on the software vulnerabilities of networked medical devices that are already on the market. The guidance focuses on the importance of...more

No Trade Dress Protection For Pink Ceramic Hip Implant Components

The U.S. District Court for the District of Colorado recently denied a manufacturer of ceramic medical products trade dress protection for the color pink for its ceramic hip-implant components. CeramTec sells ceramic...more

HHS Finalizes Toned-Down Version of Common Rule Overhaul

The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data...more

Plaintiffs’ Fraudulent Joinder Tactic Results in Dismissal

Defendants successfully argued “fraudulent joinder” in Bahalim v. Ferring Pharmaceuticals, Inc., winning dismissal of the case in its entirety. The case was decided on Plaintiffs’ motion to remand and Defendants’ motions to...more

Capitol Hill Healthcare Update

House Speaker Paul Ryan last week set a deadline of the end of March for repealing most of the Affordable Care Act (ACA), as other Republican leaders and conservative rank-and-file lawmakers advocated competing policy...more

Gorsuch Looks Pretty Good On Preemption

When we heard about Judge Neil Gorsuch being nominated for the United States Supreme Court, our first move was to enter his name in Westlaw along with the term “preemption.” That’s the constitutional doctrine most important...more

Life Sciences. Major Russian legislation changes for 2016

We would like to present the overview of the most important legislation changes in life sciences for 2016....more

RX IP Update - January 2017

Apotex’s Infringement of AstraZeneca’s Omeprazole Formulation Patent Upheld - As previously reported, the Federal Court of Appeal, in a unanimous decision released on January 12, 2017 (2017 FCA 9), has affirmed the...more

France imposes an extra notification obligation on Class III and implantable medical devices manufacturers

On 13 December 2016, the French Decree 2016-1716[1] implementing the French Law 2016-41 modernising the French healthcare system[2] (“French Law 2016-41”) was adopted. This Decree provides important information concerning the...more

Stryker Accolade TMZF and L-Fit V40 Chrome/Cobalt Head Failures – Not Just a Large Head Problem, Or Is It a Head Problem At All?

For over four years I have been investigating problems associated with Stryker Accolade TMZF Titanium hip stems. Of course the Rejuvenate and ABG II failures and subsequent recall are well-known and much written about. But,...more

Talk This Way: FDA Provides Guidelines on Medical Product Communications Consistent With the FDA-Required Labeling

Channeling Aerosmith’s 1975 single, “Walk This Way,” and the song lyric “Talk This Way,” the Food and Drug Administration issued a draft guidance to industry on how it can communicate certain types of product information...more

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