Device Advice is CDRH`s self-service site for medical device and radiation emitting product information. It is an interactive system for obtaining regulatory information concerning medical devices.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm
Medical Device Quality Systems Manual - A Small Entity Compliance Guide First Edition (Supersedes the Medical Device Good Manufacturing Practices [GMP] Manual)
The Medical Device User Fee and Modernization Act (MDUFMA) was recently reauthorized with provisions for small business, what these provisions state is that,
"This guidance explains how your business may qualify as a “small business” and pay most FY 2011 medical device user fees at substantially discounted rates; if you qualify as a small business, you may also qualify to obtain a one-time waiver of the fee for your first (ever) premarket application (premarket approval application, biologics license application, product development protocol, or premarket report)."
The full text of this act is available at the following hyperlink http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/UCM220820.pdf
Research by Eliza Brannigan & Kristin Stiner
