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Medical Devices › Toxic Chemicals

ArentFox Schiff

FDA Declares PFAS Polymers in Medical Devices Safe and Currently Irreplaceable

ArentFox Schiff on

On August 6, the US Food and Drug Administration (FDA) issued an update regarding the use of per- and polyfluoroalkyl substances (PFAS), specifically fluoropolymers such as polytetrafluoroethylene (PTFE), in medical devices....more

Goldberg Segalla

Does EtO’s Recent Regulatory Battle Victory Mean It Will Win the War?

Goldberg Segalla on

Following years of heightened concern about the dangers of exposure to ethylene oxide (EtO), increased regulatory oversight, and a steady hum of litigation, in 2025 it seems like things might be changing for the beleaguered...more

Akin Gump Strauss Hauer & Feld LLP

Regulatory Relief for Certain Stationary Sources to Promote American Security with Respect to Sterile Medical Equipment (Trump EO...

Akin Gump Strauss Hauer & Feld LLP on

This proclamation addresses the EPA’s April 5, 2024 final rule, National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review, 89...more

Hogan Lovells

PRODUCT | PFAS and product law: Navigating regulatory and legal risks

Hogan Lovells on

Regulation and litigation surrounding per- and polyfluoroalkyl substances (PFAS) – a class of organic chemicals used in a variety of industrial and consumer products – is on the rise and evolving day-by-day. And the PFAS...more

Faegre Drinker Biddle & Reath LLP

Biden’s 11th-Hour Ethylene Oxide Decision Continues the Environmental Protection Agency’s Expansion Into Occupational Safety

Faegre Drinker Biddle & Reath LLP on

On January 14, 2025, the Biden administration’s U.S. Environmental Protection Agency (EPA) posted a last-minute “interim” decision in the Federal Register for its review of ethylene oxide (EtO) under the Federal Insecticide,...more

Faegre Drinker Biddle & Reath LLP

Biopharma & Medical Device Briefing: PFAS Reporting Requirements; ECHA Substances of Very High Concern List; and MicroRNA...

Faegre Drinker Biddle & Reath LLP on

With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more

Goldberg Segalla

Lawsuits Claim EPA’s EtO Rules are Too Little, Too Late

Goldberg Segalla on

Following the U.S. Environmental Protection Agency’s 2016 finding that ethylene oxide (EtO), a highly effective chemical routinely used to sterilize medical devices and equipment, was significantly more hazardous than...more

King & Spalding

EU Aims for Ban of PFAS. Now is the Time to Act.

King & Spalding on

Earlier this year, the European Chemicals Agency (ECHA) published a proposal for a ban on the production, use and placing on the market (including import) of at least 10,000 per- and polyfluoroalkyl substances (PFAS)....more

Console and Associates, P.C.

Medical Device Manufacturer B. Braun at the Center of Cancer Lawsuit Stemming from Ethylene Oxide Exposure

Console and Associates, P.C. on

B. Braun, a Germany-based medical device manufacturer, is facing allegations that the company’s Allentown, PA facility exposed workers and nearby residents to dangerous levels of the chemical ethylene oxide. Ethylene oxide...more

Console and Associates, P.C.

Philips CPAP Recall Update: Shocking Revelation From FDA Investigations and More

Console and Associates, P.C. on

What is the latest with the CPAP lawsuits? As 2022 begins, the thoughts of sleep apnea patients and their families are, naturally, returning to the Philips CPAP machine recall 2021....more

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