News & Analysis as of

Manufacturers Distributors Medical Devices

Lathrop GPM

Seventh Circuit Court of Appeals Affirms District Court’s Partial Dismissal of Complaint for Breach of Distributor Agreement by...

Lathrop GPM on

The Seventh Circuit Court of Appeals recently affirmed a district court’s dismissal of two claims brought by distributors against the medical-device manufacturer Zimmer Biomet. It also affirmed a jury verdict in favor of the...more

Jones Day

Reversal of Burden of Proof Under Proposal for a New EU Product Liability Directive

Jones Day on

In Short - The Situation: The EU Product Liability Directive 85/374/EEC ("PLD") was adopted nearly 40 years ago and has remained almost unchanged since its inception....more

Arnall Golden Gregory LLP

I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under...

AGG is proud to introduce our newest podcast series titled “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues.” Each month, we will release a new podcast where different members of our Food and Drug practice...more

Sheppard Mullin Richter & Hampton LLP

Not So Fast – FDA Retracts Authorization for Some Respirators Made in China

Immunity under the Public Readiness and Emergency Preparedness (“PREP”) Act is a moving target for government contractors and other companies manufacturing or distributing personal protective equipment (PPE) in the COVID-19...more

Goodwin

Qualifying for Immunity Under the U.S. PREP Act During COVID-19

Goodwin on

As part of the U.S. government’s response to the COVID-19 pandemic, on March 10, 2020, the Secretary of Health and Human Services (“Secretary”) issued a Declaration pursuant to the Public Readiness and Emergency Preparedness...more

Sheppard Mullin Richter & Hampton LLP

Families First Coronavirus Response Act: Face Mask Manufacturers and Distributors Protected from Liability for Coronavirus Deaths

On March 18, 2020, the President signed into law the Families First Coronavirus Response Act, H.R. 6201, Pub. L. No. 116-127 (the “Coronavirus Response Act”). Among other measures in response to the current pandemic, this...more

Mintz - Health Care Viewpoints

Update on FDA’s Comprehensive Regenerative Medicine Policies and Enforcement Activities

Since our 2018 year-end post on the busy FDA regulatory agenda, we are nearing the halfway mark of the “grace period” the Agency has extended for certain regenerative medicine product developers to come into compliance by...more

Akin Gump Strauss Hauer & Feld LLP

A Client’s Guide to FDA Recalls

Recent FDA Recall Highlights & Developments - • The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff, providing recommendations regarding the...more

Jones Day

French Court Clarifies Surveillance Obligations

Jones Day on

The Situation: In a recent decision, the French Supreme Court clarified the surveillance obligations of notified bodies—independent entities accredited by an EU Member State's national health authority to determine whether a...more

Jones Day

France Simplifies Local Medical Device Regulations and Sets Precedent for Other Member States

Jones Day on

On April 26, 2018, the French administrative Supreme Court (Conseil d'Etat) issued a ruling that annulled Decree 2016-1716 of December 13, 2016 ("2016 Decree") related to the summary of characteristics for medical devices....more

Hogan Lovells

Brexit – what’s next for medical devices?

Hogan Lovells on

On 22 January 2018, the European Commission released a notice to stakeholders concerning the United Kingdom’s (“UK”) possible withdrawal from the European Union (“EU”) and the EU rules in the field of industrial products,...more

Stinson LLP

FDA Attempts to Clarify Enforcement Position Regarding Evolving Health Technology

Stinson LLP on

Recently, the U.S. Food and Drug Administration (FDA) has issued a flurry of guidance and draft guidance in an effort to better define the types of products that the FDA will choose to actively regulate. In one of these...more

12 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide