More information: Alexander O Everhart et al, Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study, BMJ (2025). DOI: 10.1136 ...

Dublin, March 18, 2025 (GLOBE NEWSWIRE) -- The "Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course" has been added to ResearchAndMarkets.com's offering.

Nearly a third of medical device adverse events were not submitted to the FDA within a 30-day regulatory window, with most ...

The U.S. Food and Drug Administration has released more than 20 years of reports detailing adverse events involving medical devices, ending a program that allowed some manufacturers to keep safety ...

Almost a third of medical device adverse events (AEs) were reported by manufacturers later than the US Food and Drug Administration’s (FDA) required 30-day window across a three-year period ...

The Materiovigilance Programme of India (MvPI), under the Indian Pharmacopoeia Commission, has released the updated version of the medical devices adverse event reporting form, for the use of ...

Overall, 71.0% of adverse events were reported within 30 days (on time), while 4.5 and 9.1% were reported between 31 and 180 days or after 180 days, respectively. HealthDay News — Although most ...