MAUDE - Manufacturer and User Facility Device Experience. MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. Also, warning letters issued to device makers for FDA violations.
This is from Harvard law school. You can download the PDF. It's from 1989 and is a great explanation of the intended puprose of pre-Market approval as it was originally intended:http://jolt.law.harvard.edu/articles/pd ... ech001.pdf
"It is a good thing to learn caution from the misfortunes of others."
"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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