News & Analysis as of

Manufacturers Medical Devices

FDA Pushes UDI System Compliance Date Back for Class I and Unclassified Devices

by Hogan Lovells on

On June 2, 2017, the U.S. Food and Drug Administration (FDA) announced in a letter to device labelers that it will issue a guidance document stating that FDA will exercise its enforcement discretion for the unique device...more

Filling in the Gaps on Medical Device Cybersecurity

by Hogan Lovells on

Cybersecurity has become a hot button topic for many in the medical device industry following the announcement of several high-profile medical device vulnerabilities and in light of the recent WannaCry ransomware attack that...more

Medical devices – South Africa's changing landscape

by Hogan Lovells on

Subject to certain exceptions, medical devices have historically not been heavily regulated in South Africa.  Prescriptive requirements for medical devices were not in force and advertisers and marketers of medical devices...more

New European Medical Device Regulations Will Become Effective on May 25, 2017

by King & Spalding on

On May 5, 2017 the European Union legislator published Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices - the EU-Medical Devices Regulations (MDRs) in the...more

Fourth Circuit Excludes FDA Evidence in Transvaginal Mesh Products Liability Case

by Sands Anderson PC on

In the Southern District of West Virginia, Johnson & Johnson and its subsidiary, Ethicon, Inc., were sued for defective design and failure to warn for their transvaginal mesh TVT-O, in addition to a loss of consortium claim....more

Health Care Provider Insights - Introductory Edition

by Wilson Elser on

Welcome to the introductory edition of Health Care Provider Insights. We are practice management consultants, providing legal and business management advice and assistance to physicians and dentists (health care...more

Lack of Specificity May Kill Parallel State Law Product Claims, But Not Fraud Claim

by Cozen O'Connor on

A Michigan district court judge determined last week that product liability claims against an FDA approved medical device manufacturer were preempted by federal law, but allowed the plaintiff’s claim of fraud against the...more

Medical Device Regulation Update

by K&L Gates LLP on

On 5 May 2017, the Medical Device Regulation ("MDR") was published in the Official Journal of the European Union and comes into effect on 26 May 2017. The Commission proposed back in 2012 to revise the existing regulatory...more

Blues Defeat Antitrust Claim by Heart Monitoring Device Maker

by Baker Ober Health Law on

On April 3, Judge Eduardo Robreno, District Judge for the Eastern District of Pennsylvania, granted judgment to a collection of insurer defendants in an antitrust conspiracy case brought against them by heart monitoring...more

The Continuing Story of Manufacturers' Off-Label Promotion of Approved or Cleared Medical Products

by Jones Day on

Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products. On January 18, 2017, FDA published two...more

Guest Post – Come Together: Is UK Product Liability Law Getting More Like the U.S.?

by Reed Smith on

This guest post – only our second post ever on European issues is brought to you by Reed Smith partners Marilyn Moberg and (in the UK) associate Bond, Kathryn Bond (sorry, couldn’t resist). Our previous (and only) foray into...more

Medical Device Manufacturers’ Duty to Warn Expands

by Knobbe Martens on

The Washington State Supreme Court recently released its decision in Taylor v. Intuitive Surgical, Inc. where it held that Washington law requires medical device manufacturers to warn hospitals that purchase their products of...more

The MHRA issues new guidance concerning Own Brand Labelling or "Virtual Manufacturing"

by Hogan Lovells on

On 29 March 2017, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a new guidance (hereafter “Guidance“) concerning the Own Brand Labelling of medical devices in the United Kingdom. The Guidance,...more

The Future of “Single Use Restrictions” in Jeopardy

by Knobbe Martens on

In 1992, the United States Court of Appeals for the Federal Circuit held that manufacturers of patented medical devices can use the patent laws to enforce single-use restrictions on medical devices. Mallinckrodt, Inc. v....more

FDA to Exempt Over 1,000 Types of Medical Devices from Premarket Notification Requirements

by Saul Ewing LLP on

On March 13, 2017, the U.S. Food and Drug Administration (FDA or the Agency) identified a list of 1,003 types of Class II medical devices that, when finalized, will be exempt from the Agency’s premarket notification (i.e.,...more

Washington: Product Manufacturers Must Warn Hospitals; May Be Strictly Liable for Failure to Warn

by Cozen O'Connor on

In Washington, manufacturers of medical devices now have a duty to warn hospitals that purchase their devices. Additionally, product manufacturers of “unavoidably unsafe products” face strict liability for failure to warn...more

What The Intuitive Ruling Means For Medical Device Makers

by Morrison & Foerster LLP on

Last month, in Taylor v. Intuitive Surgical Inc., 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...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

International Product Liability Review - Issue 65

by Hogan Lovells on

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

by Ropes & Gray LLP on

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

by Morgan Lewis on

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

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

by Locke Lord LLP on

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

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

by Hogan Lovells on

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

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

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

by Pepper Hamilton LLP on

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

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