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The overhauling of the FDA’s oversight of in vitro diagnostics will see significant movement in 2023, according to Andi Fristedt, the agency’s deputy commissioner for policy, legislation and international affairs.
Three years after closing its Willowbrook, Ill., medical device sterilization facility, Sterigenics and its parent company Sotera Health have announced a $408 million settlement of the more than 870 cases pending against it for claims that the use of ethylene oxide led to higher cancer rates near the plant.
Applications to the FDA for new devices that cited predicate devices subject to ongoing recalls resulted a higher risk of recall of the new devices, two research teams reported in the Journal of the American Medical Association (JAMA).
The FDA offers advice for 510(k) marketing submissions for photobiomodulation (PBM) devices — also known as low-level light therapy (LLLT) devices — in a new draft guidance.
An administrative law judge in Washington D.C., has ruled that certain Apple watches, starting with 2020’s Series 6 and continuing through current versions, infringe on pulse oximeter patents held by Masimo. The U.S. International Trade Commission will now consider whether to implement a ban on imports of the watches.
The FDA has closed out a warning letter sent to Dayton, Ohio-based Innovative Sterilization Technologies (IST) in 2019 for marketing a reusable sterilization container for uses the agency had not cleared, the company said.