On January 18, 2009, the Project on Government Oversight published a report pointing out FDA’s showing the agency deliberately backed off of "Good Laboratory Practice" requirements for medical device makers. In doing so, the agency allowed device companies to test their products on humans without proving that the tests adhered to standards observed for three decades.
See http://www.pogo.org/pogo-files/reports/public-health/safety-of-medical-d...