News & Analysis as of

Medical Devices Crisis Management

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: Product Liability and Mass Torts

Morrison Foerster Investigations + White Collar Defense partner Nate Mendell, former Acting U.S. Attorney for the District of Massachusetts, hosted the fourth episode of When Your Life Sciences Are on the Line, where leading...more

Jones Day

EU Emergency Response Update – Key Policy & Regulatory Developments No. 110

Jones Day on

This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

McDermott Will & Emery

[Webinar] Critical Business Considerations for Life Sciences and Medical Device Companies Amid the COVID-19 Pandemic - April 17th,...

McDermott Will & Emery on

Life sciences and medical device companies are dealing with an unprecedented crisis. The industry is not only managing the impact of Coronavirus (COVID-19), they are also a solution provider. Companies are rapidly adapting...more

McDermott Will & Emery

FDA Update: Enforcement Policies for Gowns, Gloves, Sterilizers, Disinfectant Devices and Air Purifiers

McDermott Will & Emery on

In response to growing medical product supply shortages and need for information, the US Food and Drug Administration (FDA) has recently issued multiple enforcement policies to provide guidance to industry. Here, we focus on...more

Foley & Lardner LLP

OSHA Guidance Allows Alternatives in Light of N95 Shortage Due to Coronavirus

Foley & Lardner LLP on

On April 3, 2020, OSHA issued enforcement guidance that temporarily permits the extended and re-use of respirators as well as other alternatives, and clarifies when respirators, including N95 masks, may continue to be used...more

ArentFox Schiff

The Transport of Coronavirus by Exhaled Breath and Possible Protection with Homemade Face Coverings

ArentFox Schiff on

As recently as March 27, the WHO was stating on its website that there was insufficient evidence to suggest that the novel coronavirus was airborne except in a handful of medical cases, such as when intubating an infected...more

Seyfarth Shaw LLP

CDC Provides Recommendations for Respirators When N95 Respirators Are Not Available in COVID-19 Crisis

Seyfarth Shaw LLP on

To combat shortages of N95 respirators, the Centers for Disease Control and Prevention issued and continues to update its Strategies for Optimizing the Supply of N95 Respirators. The CDC’s N95 Respirator Strategies provide...more

Morgan Lewis

FDA Suspends Routine Domestic Drug and Device Inspections Due to COVID-19

Morgan Lewis on

For-cause inspections will proceed if deemed “mission critical.” The US Food and Drug Administration (FDA) had previously announced on March 10 that routine foreign inspections were suspended. FDA suggests that it may attempt...more

Hogan Lovells

The global impact of COVID-19 on clinical trials and countermeasure development

Hogan Lovells on

The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more

Morgan Lewis

Recent FDA Medical Device Developments in Response to COVID-19

Morgan Lewis on

The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more

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