AG/FDA Blog

MDR Reporting of Foreign Adverse Events -- What is Your Obligation?

Under the U.S. Food and Drug Administration’s (FDA) Medical Device Reporting (MDR) Regulation, 21 C.F.R. Part 803, medical device manufacturers must report adverse events involving their devices to FDA when information reasonably suggests that: Th… Read More
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Adverse Event Reporting for Medical Devices and the Law: Where Has FDA Gone Wrong?

On September 27, 2007, President George W. Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007 (“FDAAA”).  FDAAA both enhances and curtails FDA’s authority in many respects.  Specifically, FDAAA removes a r… Read More
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