Study: Nearly a Third of Device Manufacturer Adverse Event Reports Do Not Meet Regulatory Deadlines
March 26, 2025 at 07:16 PM EST
A study of submissions to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database has revealed that “nearly a third of manufacturer reports of medical device adverse events were not demonstrably submitted to the FDA within the regulatory deadline, with most late reports being submitted more than six months after manufacturer notification,” according to rese... Read More
