The Food and Drug Administration (FDA) is an agency Department of Health and Human Services in USA. It c***ists of the Office of the Commissioner and four directorates overseeing the core functi*** of the agency: Medical Products and Tobacco, Foods, Global Regulatory Operati*** and Policy, and Operati***.
FDA is resp***ible for
- Protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled and that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective
- Protecting the public from electronic product radiation
- Assuring co***etics and dietary supplements are safe and properly labeled
- Regulating tobacco products
- Advancing the public health by helping to accelerate product innovati***
- Helping the public get the accurate science-based information they need to use medicines, devices, and foods to improve their health
FDA’s resp***ibilities extend to the 50 States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessi***.
Besides, FDA regulates a broad range of medical devices, including complicated, high-risk medical devices, like artificial hearts, and relatively simple, low-risk devices, like tongue depressors, as well as devices that fall somewhere in between, like sutures. FDA has authority to regulate medical devices before and after they reach the marketplace.
O***unda medical device c***ulting organization also provides FDA c***ulting project within its company. It was found in 2004, which mainly focuses on medical devices. Its c***ultant projects include SFDA registration, international medical devices registration, devices quality system certification, GMP for medical devices, medical devices training and other projects. It is the largest and most professional c***ulting organization in the field of Medical Device in China.