US FDA certification
The Food and Drug Administration (FDA), a part of the U.S. Department of Health, is licensed by the U.S. Congress and the federal government to specialize in food, pharmaceuticals, cosmetics, biological products, medical devices, and radiation laser electronics product management . FDA's role is to implement the Federal Food, Drug and Cosmetic Act, the Fair Packaging and Labeling Act, the Public Health Services Act, the Medical Device Safety Code, the Medical Device Amendment and other laws and regulations, To ensure that the United States on the market all the food, medicines, cosmetics and medical equipment, etc. to the human body safe and effective. Imported goods and U.S. domestic products must also comply with the relevant U.S. law requirements. Every year, a large number of medical device products in our country are rejected for import due to non-compliance with the relevant regulations and requirements of the FDA. Products are stranded in Customs, confiscated or forcibly returned to the country, bringing huge economic losses to domestic exporters and manufacturing enterprises. To this end, understanding the requirements and regulations of the FDA on medical devices is of positive significance for promoting the export of medical device products to the United States.
Definition medical device FDA
In the United States, there are thousands of types of medical devices, ranging from contact lenses, medical gloves, scalpels, massagers, pacemakers, thermometers, thermos pads, tongue depressors and wheelchairs to B-ultrasound Machine, kidney machine, spiral CT and other professional medical equipment. All products related to health care, rather than drugs, fall into the category of medical devices. 201 (h) of the Federal Food, Drug and Cosmetic Act defines "Medical Device" as "an instrument, device, tool, machine, device, implant, in vitro reagent, or other similar or Related items, including components, parts or accessories All of these:
- as recognized in the "U.S. National Prescription Set" or "USP" or their supplements;
- is intended for the diagnosis of a human or animal disease or other condition or for the treatment, mitigation, treatment or prevention of a disease, or - is intended to affect the body structure or any function of a human or animal, but not by in vivo or in vivo The chemistry of the table does not rely on metabolism to achieve its intended goal. "
Products that meet the above definition are considered medical devices and such products must be FDA-approved for marketing in the United States. According to the above definition, medical devices, as products that maintain good health, do not include products designed to treat diseases through chemical reactions or metabolism inside and outside the body; drugs that act through chemical reactions or metabolism.
Which agency issued the FDA certificate?
FDA registration is not a certificate, the product by registration at the FDA, will obtain the registration number, the FDA will give the applicant a reply (with the FDA's chief executive's signature), but no FDA certificate said.
Food FDA registration related to product categories which are?
Cosmetics FDA certification programs have?
Medical Devices FDA registration how to apply?
Radiation laser electronics FDA registration process?
Please click below for more details.