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The Center for Devices and Radiological Health (CDRH) issued 39 final guidances in 2022, nearly doubling the 21 issued the previous year, but it was a Feb. 23 draft rule that garnered the most attention — Medical Devices; Quality System Regulation Amendments — that proposes to align the 20-year-old FDA quality system requirements (QSR) with International Organization for Standardization (ISO) requirements.
With user fee legislation now firmly in place, a new Congress ready to begin legislating in 2023, and an omnibus package signed into law funding the FDA for another year, we talked with Steven Grossman, executive director of the Alliance for a Stronger FDA, about the big issues that face the agency as we head into the new year.
Medical device distributor Jet Medical has agreed to pay $200,000 in criminal penalties to settle allegations that it misbranded its Allevio SPG nerve block catheter as a migraine device.
Devicemakers can request an exemption to submit adverse event data from real-world data (RWD) sources in formats other than the FDA’s electronic reporting format, the agency said in an update of its web page on medical device report (MDR) exception requests.
The FDA has updated its Recognized Consensus Standards database, known as “List 59,” with several new standards as well as revisions to three existing standards.
The FDA started the year with a soft launch of its Total Product Life Cycle Advisory Program (TAP) pilot, with the intention of enrolling up to 15 devices in fiscal 2023.
Pediatric use of medical devices “requires considerations such as growth and development, anatomical and physiological differences, hormonal influences, and activity level,” the NCC-PDI says.
While the FDA regulates medical devices, it shares oversight of how devices are promoted with the Federal Trade Commission (FTC). This oversight extends to social media, where many companies find avenues for product promotion — and various ways in which advertising can go afoul of the law.
The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) and the Children’s National Hospital are inviting applications from manufacturers with already-cleared devices to use real world evidence (RWE) to gain FDA clearance for pediatric use.
The FDA has granted Class II designations — with general or special controls to assure safety — for several categories of devices submitted to the agency through the De Novo review pathway.