(FDA) An agency of the US federal government established by Congress in 1912 and presently part of the US Department of Health and Human Services. The FDA gives classifications of medical devices according to potential risks and controls the safety of marketed drugs.

See also Class I II III Devices, Phase 1 2 3 4 Drug Trials and Legal Requirements.

(SFDA) The State Food and Drug Administration of the People's Republic of China was founded in November 2003 and is directly under the State Council. The State Food and Drug Administration is in charge of comprehensive supervision on the safety management of food, health food and cosmetics and is the competent authority of drug regulation. For drug or medical device registration please see the SFDA's Regulatory Guide.
The agency is China's equivalent of the US Food and Drug Administration.

Short name: Ami 227, generic name: Ferumoxtran, (USPIO)
Ferumoxtran is a substance of the class of ultrasmall superparamagnetic iron oxide used as a lymph node specific contrast agent for MRI.
See also Combidex®, Sinerem® and Ultrasmall Superparamagnetic Iron Oxide.
Partner(s): Cytogen Corporation, National Cancer Institute. An approvable letter was received from the U.S. Food and Drug Administration for Combidex in June 2000. Advanced Magnetics, Inc. has submitted a complete response to the approvable letter received from the U.S. Food and Drug Administration, which was accepted by the FDA and assigned a user fee goal date of March 30, 2005. In Europe, a Dossier (the European equivalent of a NDA) was submitted by Advanced Magnetics' European partner, Guerbet SA, to the European Medicines Evaluations Agency in December 1999. (Sinerem® is the brand name for this USPIO in Europe manufactured by Guerbet, Combidex® by Advanced Magnetics for the U.S. market)
Advanced Magnetics, Inc. changed its name in July 2007 to AMAG Pharmaceuticals Inc.

From Aurora Imaging Technology, Inc.;
The Aurora® 1.5T Dedicated Breast MRI System with Bilateral SpiralRODEO™ is the first and only FDA approved MRI device designed specifically for breast imaging. The Aurora System, which is already in clinical use at a growing number of leading breast care centers in the US, Europe, got in December 2006 also the approval from the State Food and Drug Administration of the People's Republic of China (SFDA).
'Some of the proprietary and distinguishing features of the Aurora System include: 1) an ellipsoid magnetic shim that provides coverage of both breasts, the chest wall and bilateral axillary lymph nodes; 2) a precision gradient coil with the high linearity required for high resolution spiral reconstruction;; 3) a patient-handling table that provides patient comfort and procedural utility; 4) a fully integrated Interventional System for MRI guided biopsy and localization; and 5) the user-friendly AuroraCADâ„¢ computer-aided image display system designed to improve the accuracy and efficiency of diagnostic interpretations.'

Classification by the Food and Drug Administration of medical devices according to potential MRI risks or hazards.