On January 1, 2021, the UK launched its very own emissions trading scheme (the “UK ETS”) exercising its autonomy since departing the EU. Under this scheme, companies operating in.
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ASTM International recently approved a new performance standard that will tell consumers just how much protection their cloth face masks offer. Some face coverings like N-95 respirators and surgical masks must meet certain filtration requirements enforced by government agencies like the U.S. Occupational Safety and Health Administration (OSHA) and the U.S. Food and Drug Administration (FDA). But, until recently, other masks like reusable gaiters and cloth face coverings had no performance standards whatsoever, making it impossible for consumers to judge how protective their masks were or to compare one mask to another.
On December 11, 2020, a SARS-CoV-2 (COVID-19) vaccine developed by Pfizer and BioNTech became the first to receive Emergency Use Authorization (EUA) from the U.S. Food and Drug.
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In February, the Consumer Technology Association (CTA) announced a voluntary standard for healthcare products that use Artificial Intelligence (AI). This standard follows the Food and Drug Administration’s (FDA) recently published action plan for regulatory oversight of AI and machine learning-based medical software. FDA ultimately determines the regulatory process and requirements to legally market AI healthcare products, generally reviewing products to make sure they are safe and effective for the consumer market. FDA has worked to adopt a new regulatory framework for AI/ML software medical devices for years now. But as ANSI/CTA‑2090 suggests, regulatory approval is just one consideration for this novel product category.
The Ninth Circuit recently weighed in on the appeal of a False Claims Act lawsuit from a relator against Medtronic. In this case, the relator alleges that Medtronic, Inc.: .