The FCC is the abbreviation of the Federal Communications Commission of the United States, but also the United States of America on the mandatory certification of electronic products, divided into ID, DOC, VOC three categories.FDA's responsibility is to ensure that the United States of America's domestic production or import of food, cosmetics, drugs, biological agents, equipment and radiological products are safe.FDA is the Food and Drug Administration (Food and Drug Administration) abbreviation, FDA registration covers cosmetics, food, medical devices, drugs, lasers and other products for registration. Drug Administration), FDA registration covers cosmetics, food, medical devices, drugs, lasers and other products for registration. According to the different risk level, FDA will medical devices are divided into three categories (Ⅰ, Ⅱ, Ⅲ), Ⅲ class risk level is the highest, the higher the category of the more stringent regulation.FDA will be each kind of medical devices are clearly specified in its product classification and management requirements, and the FDA medical device product catalog has been included in more than 1700 kinds of products.
According to the FDA's medical device regulations, electric breast pumps are classified as Class II medical devices and require a 510k application and premarket notification before they can be listed for registration.