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Events that meet the IRB’s reporting criteria should be promptly submitted to the IRB using the electronic Problem Report Form. See the timeline table ... A reportable event is any unanticipated ...

BD, Medtronic and Abbott were among the top 10 device companies with the highest number of late reports to the FDA, the study ...

The Materiovigilance Programme of India (MvPI), under the Indian Pharmacopoeia Commission (IPC), has released the draft in-vitro diagnostic medical device (IVD-MD) adverse event reporting form and has ...

Some unanticipated problems, such as adverse ... report to the HSRO any of the following circumstances promptly and within 7 days of the date the investigator first becomes aware of the problem.