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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.
An FDA inspection of East Troy, Wis., implantable medical device manufacturer Cytophil showed unvalidated processes and inadequate testing, among other lapses.
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 company says the product is “the first and only inhaled MRI hyperpolarized contrast agent for novel visualization of lung ventilation without exposing patients to any ionizing radiation and its associated risks.”