FDAnews
www.fdanews.com/articles/143563-fda-rsquo-s-medical-device-ombudsman-details-complaints

FDA’s Medical Device Ombudsman Details Complaints

January 30, 2012
The ombudsman’s office for the FDA’s medical device arm released details of the contacts it had with the public last year, including complaints about the watchdog agency’s reviews of medical technology.
MassDevice