Are You Ready for Electronic MDR Reporting?

Paper medical device reports (MDR) will soon be a thing of the past. On August 14, 2015, the electronic MDR final rule goes into effect, requiring manufacturers, importers and other firms responsible for reporting to submit MDRs to the FDA electronic… Read More
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Ask Not for Whom the Bell Tolls, it Tolls for Your LDT (Part II)

In our prior posting, we provided a brief overview of the notification and adverse event reporting requirements that will apply to the vast majority of a subset of in vitro diagnostic devices known as Laboratory Developed Tests (LDTs), most likely in… Read More
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Ask Not for Whom the Bell Tolls, it Tolls for Your LDT (Part I)

On October 3 of this year, the Food and Drug Administration (FDA) published draft guidance documents that, when finalized, will mark a “game changer” for clinical laboratories. Specifically, these guidances call for the active regulation of a sub… Read More
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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: The… 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 requi… Read More
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