The ombudsman of FDA's Center for Devices and Radiological Health reported that it had 461 contacts with the public in 2011, up 11% from the previous year. These contacts include complaints about the FDA's medical device review process, as well as other contacts that never rise to the level of a complaint. Inquiries from the medical device industry accounted for nearly two-thirds of all contacts in 2011.

The ombudsman's report can be accessed at FDA's website.

-Richard Park