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--(BUSINESS WIRE)--The "Latest Chinese Guidebook for Medical Device Adverse Events Reporting, Monitoring and Re-Evaluation" report 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 ...

A significant number of medical device adverse events that resulted in patient deaths were miscategorized in the FDA's Manufacturer and User Facility Device Experience (MAUDE) database ...

A bill introduced in Congress Wednesday would require doctors to report adverse events from medical devices to the U.S. Food and Drug Administration. The legislation, known as the "Medical ...

Adverse events are defined by the FDA as any undesirable experience associated with the use of a medical product in a patient. Once manufacturers or distributors become aware of device-related adverse ...

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 ...

The Medical Device Guardians Act would require physicians and physicians’ offices to report any adverse events that arise after the use or implantation of a medical device. The bill stems from ...

Dublin, Nov. 03, 2022 (GLOBE NEWSWIRE) -- The "Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course" conference has been added to ResearchAndMarkets.com's ...

However, both the number of the most serious medical device recalls and volume of adverse event reports have risen over the ensuing decade, raising questions about whether FDA’s current ...