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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.”
Buffalo, N.Y.-based Pedia Parents was handed a Form 483 after a July inspection found the company lacked adequate procedures for supplier monitoring, design verifications and medical device reports (MDR), among other lapses.
The FDA has cleared three Polarean Xenoview imaging devices that work together to enable the company’s hyperpolarized gas blend contrast agent to deliver lung ventilation scans without the use of radioactive gas.
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.