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The sponsor of a device study “is generally better positioned than the individual investigator” to assess unanticipated adverse device effects, the FDA said in a new guidance. Read More
Device trade group AdvaMed has filed an amicus brief in the California Court of Appeal backing Johnson & Johnson’s (J&J) appeal of the $344 million verdict against the company early last year for allegedly deceiving consumers about its pelvic mesh products. Read More
The recall of millions of Philips Respironics continuous positive airway pressure (CPAP) devices for treatment of sleep apnea continues to impact activities that would not automatically come to mind, such as commercial trucking. Read More
The FDA’s Center for Devices and Radiologic Health (CDRH) seems to have gotten bogged down in its efforts to meet its commitments under the fourth iteration of the Medical Device User Fee and Modernization Act (MDUFA IV), according to the consultancy Booz Allen Hamilton. Read More
Eudamed, the European database on medical devices, will be offline for several days to allow for a “major upgrade” as new functions are about to come online, the European Commission said. Read More
The FDA’s current system of device approvals is letting serious safety problems slip through the cracks, suggests an editorial in the American Medical Association’s Journal of Ethics. Read More
The FDA’s Safer Technologies Program (STeP) for Devices provides similar agency resources and priority review to sponsors whose devices do not meet the criteria for breakthrough status. Read More
Regulatory authorities in several countries are concerned about a prenatal test made by Shenzhen, China-based BGI group that screens for Down syndrome and other genetic conditions. Available in 52 countries, the prenatal test collects DNA of women and fetuses. Read More