[http://www.fda.gov/cdrh/index.html]
CDHR is responsible for regulating medical devices and eliminating unnecessary human exposure to man-made radiation from medical, occupational and consumer products. CDRH reviews new medical devices, sets standards and regulations for devices, monitors manufacturer compliance with these regulations, and collects data on injuries and malfunctions of medical devices. CDHR also provide technical assistance to small manufacturers.
http://www.fda.gov/cdrh/industry/support/. This site offers assistance and information to small businesses and other medical device manufacturers. This includes a list of upcoming workshops and teleconferences dealing with FDA approval of medical devices, the Device Advice page on product and regulatory information, as well as manuals, regulations, and frequently asked questions.
Research by Margaret Rich
