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FDA final Clinical Decision Support guidance significantly expands on interpretations under 21st Century Cures Act
Almost three years after the last draft was released, FDA has now published a final guidance on Clinical Decision Support (CDS) software functions. The new final guidance includes comprehensive examples of when the FDA considers certain CDS functions to be medical devices and provides new and expanded interpretations of how FDA will apply statutory provisions of the 21st Century Cures Act.
First combined Covid/monkeypox town hall focuses on new guidance, expectations
Leadership from the CDRH Office of In Vitro Diagnostics (OHT7) held their first combined call on Covid-19 and monkeypox test development and regulation on September 28, following weekly monkeypox calls and now-monthly Covid policies. At the town hall-style call, regulators discussed new changes to the Covid-19 test EUA system and how to move forward with authorized tests.
OSHA Expands Criteria for Severe Violator Program
The Occupational Safety and Hazard Administration announced new instructions for the Severe Violator Enforcement Program, significantly updating the program that was begun in 2010. The new instructions announced on September 15, 2022, will expand the types of hazards covered under the program to encourage facilities to stay up-to-date on hazard and safety regulations.
EPA Withdraws Glyphosate Interim Registration Review Decision
The EPA announced that it was withdrawing all sections of its interim registration review decisions for glyphosate after the Ninth Circuit vacated (or cancelled) the human health portions of the review in June. The move comes as Bayer, who manufactures glyphosate, gears up for additional litigation related to health issues allegedly caused by the herbicide.
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