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DePuy Synthes — a subsidiary of Johnson & Johnson — has agreed to pay $9.75 million to resolve allegations it violated the False Claims Act by paying kickbacks to a Massachusetts-based orthopedic surgeon to induce his use of DePuy products. Read More
FDA Commissioner Robert Califf laid out his priorities for “a major reformation of our national system for generating medical evidence” and wearable sensors were at the top of his list, in an article in the journal Clinical Trials. Read More
In a letter to the White House, AdvaMed defended the medical sterilization industry’s use of ethylene oxide (EtO) and asked for consideration of several points for the Environmental Protection Agency’s (EPA) proposed regulation of the sterilization process for medical devices.
The FDA has released a final rule on radiological health that revises documentation requirements, allowing more time for submitting reports for accidental radiation occurrences (AROs).
The FDA has called for suggestions for how it should make use of user fee funding for two data reporting projects — premarket real-world evidence (RWE) activities and the Medical Product Safety Network (MedSun) program, a national surveillance network to collect postmarket data on medical devices.
“Real world” is a misleading and unnecessary term when it comes to data collection, says Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), who believes real-world evidence (RWE) should be treated the same as any other clinical evidence.
The studies noted that when devices cited predicates that had been subject to Class I recalls they had a much higher risk of themselves being subject to a future recall.
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).