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Medical Devices › Risk Management › Policies and Procedures

Gardner Law

Change Control Pitfalls: Legal & Regulatory Risks in FDA-Regulated Industries

Gardner Law on

Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a natural part of the...more

Gardner Law

From Paper to Practice: Compliance Policies that Work

Gardner Law on

In the FDA-regulated industry, a compliance program isn’t just a formality—it’s a critical tool for protecting your business, patients, and reputation. Still, too many companies treat compliance policies as static...more

McDermott Will & Schulte

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

McDermott Will & Schulte 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

Outlook of China’s Health Care Sector in Light of COVID-19

Seyfarth Shaw LLP on

China is cautiously recovering from the peak of the COVID-19 outbreak and is moving into a new period of investor-friendly policies aimed at restarting China’s economic engine....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

ArentFox Schiff

FDA Issues Enforcement Policy for Ventilators and Other Respirators

ArentFox Schiff on

As part of its effort to address the shortage of medical equipment needed to address the COVID-19 pandemic, FDA has issued a new Enforcement Policy announcing flexibility in some of the regulatory requirements for...more

ArentFox Schiff

FDA Loosens Requirements for Sterilizers, Disinfectant Devices, and Air Purifiers

ArentFox Schiff on

Over the past weekend, the FDA issued yet another Final Guidance to relax the rules governing medical devices. In this new Guidance, the FDA says it is expanding “the availability and capability of sterilizers, disinfectant...more

Polsinelli

What COVID-19 Means for FDA-Regulated Industry

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U.S. and international health authorities continue to respond to the outbreak of the novel coronavirus (COVID-19). While originally detected in Wuhan City, Hubei Province, China, as of the date of this alert the virus has now...more

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