News & Analysis as of

Medical Devices Manufacturers

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Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products.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

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

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

FDA Off-Label Promotion Memo Should Affect §510k Preemption & Evidence

by Reed Smith on

Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k “substantially equivalence” medical device clearance as non-preemptive because it was supposedly “focused on equivalence, not safety”? Id. at...more

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union

by Thomas Fox on

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union - An effective Compliance risk management at emerging markets for any business significantly depends on timeous observation of changes in...more

Going After A Hospital For Off-Label Use Of A Device

by Reed Smith on

It seems that we have posted hundreds of times about attempts to impose liability on the manufacturer of a PMA device that a doctor chose to use off-label. Recently, a bunch of those have involved Infuse. Cales v. Baptist...more

21st Century Cures: A Closer Look

by McDermott Will & Emery on

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

Obama Administration Issues Changes to Iran Sanctions Regulations That Benefit Exporters of Medicine, Medical Devices and...

by Hogan Lovells on

On December 23, 2016, the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”) published a number of changes to the Iranian Transactions and Sanctions Regulations (“ITSR,” 31 C.F.R. Part 560) that expanded the...more

FDA Clarifies “Intended Use” Regulations: Knowledge Alone ? Intent, But Knowledge Certainly Can Be One Element in Establishing the...

by Hogan Lovells on

In its January 9, 2017 final rule addressing when tobacco products may be regulated as drugs, devices, or combination products, the Food and Drug Administration (“FDA” or “The Agency”) amended the intended use regulations for...more

FDA Finalizes Guidance on Postmarket Management of Medical Device Cybersecurity

by Ropes & Gray LLP on

On December 28, 2016, the Food and Drug Administration (FDA) issued final guidance on the postmarket management of cybersecurity in medical devices. The guidance outlines nonbinding recommendations on how device manufacturers...more

FDA Issues Final Guidance on Postmarket Cybersecurity

by Morgan Lewis on

Agency establishes a risk-based framework for assessment of postmarket cybersecurity risks for medical devices. On December 28, 2016, FDA issued a final guidance titled “Postmarket Management of Cybersecurity in Medical...more

FDA Guidance on Cybersecurity in Medical Devices

On December 28, 2016, the Food and Drug Administration (FDA) issued guidance on Postmarket Management of Cybersecurity in Medical Devices. The guidance clarified aspects of the reporting requirements under Part 806 (21 CFR...more

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