News & Analysis as of September 18, 2024

Occupational Safety and Health Administration › Medical Devices

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The Occupational Health and Safety Administration (OSHA) is a United States federal agency established in 1970 by the Occupational Health and Safety Act. OSHA is part of the Department of Labor and is charged... more +

The Occupational Health and Safety Administration (OSHA) is a United States federal agency established in 1970 by the Occupational Health and Safety Act. OSHA is part of the Department of Labor and is charged with assuring healthy, safe, working environments. OSHA sets and enforces safety standards and policies. Examples of OSHA's duties include setting limits on workers' exposure to hazardous substances, ensuring workers have access to safety information and protective equipment, and providing employers and workers proper training to prevent dangerous conditions. less -

FDA Warns Drug & Device Firms Against Delaying & Limiting Facility Inspections in New Draft Guidance

King & Spalding on 12/20/2022

On December 16, 2022, the U.S. Food & Drug Administration (“FDA” or “Agency”) published an important and noteworthy draft guidance document entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a...more

AGG Food & Drug Newsletter - January 2022

Arnall Golden Gregory LLP on 2/1/2022

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

The Regulation of Medical Waste During COVID-19

Pillsbury Winthrop Shaw Pittman LLP on 5/18/2020

The rapid spread of the coronavirus has generated new interest in the regulation of medical waste. The COVID-19 crisis is generating a significant amount of regulated medical waste....more

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

McDermott Will & Emery on 4/10/2020

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

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

Foley & Lardner LLP on 4/9/2020

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

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

ArentFox Schiff on 4/9/2020

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

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

Seyfarth Shaw LLP on 4/7/2020

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

Web Exclusive: The ABC’s Of AEDs

Fisher Phillips on 10/9/2017

Every time a natural disaster hits, we learn of at least one person who tragically died of a heart attack when placed in a stressful or unusual situation. Sadly, we hear little about the hundreds of thousands of other deaths...more

OSHA: Kinesiology Tape is “Medical Treatment” for Recordkeeping Purposes

Ogletree, Deakins, Nash, Smoak & Stewart,... on 12/23/2014

You have probably seen kinesiology tape, also known as KT Tape or Kinesio Tape: those bright, neon-colored tape strips worn by runners, cyclists, athletes, triathletes, and folks at the gym. In a December 12 letter of...more

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