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The commissioner called for improved “access to high-quality data from traditional clinical trials, electronic health records, and personal devices and wearable sensors.”
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.