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A sock that performs pulse oximetry measurement for infants will be available OTC for U.S. consumers by the end of this year, following the FDA’s Wednesday De Novo clearance of Owlet’s Dream Sock baby monitor. Read More
The FDA has extended the effective date of the guidance “COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers” until Aug. 7, 2024, unless a revised final guidance is issued before that date. Read More
The FDA has deemed as class I the company’s recall of certain Teleflex and Arrow International Pressure Injectable Catheter Kits for a mislabeling issue and Nurse Assist has recalled certain lots of irrigation water for a lack of sterility assurance. Read More
Attorneys general from 24 states and Washington, D.C. have sent the FDA a letter urging the agency to strengthen guidance and provide clear warning labels regarding incorrect pulse oximeter readings for patients of color. Read More
Upcoming events in the coming weeks and months include two FDA advisory committee meetings, MAGI 2024: The Clinical Research Conference as well as webinars on choosing the right IRB review partner, medical device cybersecurity and overcoming common clinical trial challenges. Read More
This edition of Quick Notes highlights the outcome of an adcomm on a device to eliminate cancer cells from blood collected during surgery, the FDA’s acceptance of a medical device cybersecurity consensus standard, and two post-market studies of cardiac device efficacy.Read More
The FDA’s final guidance on real-time oncology review (RTOR) — a program intended to facilitate review of NDAs — advises sponsors to submit in modules, at different times, enabling an earlier start to the application review process. Read More
The FDA wants its Radiological Devices Advisory Panel to weigh in on whether irradiators used to prevent metastasis in salvaged blood during cancer surgeries are safe enough to be classified as Class II devices or whether, as the FDA proposes, they should be designated as high-risk Class III devices requiring premarket approval. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
The FDA is also proposing to exempt certain clinical electronic thermometers without telethermography from premarket notification requirements. Read More