Manufacturer of Food, Drug and Medical device requires US FDA registration. US FDA Registration is required only if you are planing to market your products in the USA. The term “US FDA registration” or “FDA Registration” is often confused with term “FDA approval”. However, FDA approval and registration are two different regulatory requirements.
Graphical explanation of FDA Registration requirement.
Products like food and dietary supplements can be marketed without obtaining prior approval from FDA. However, you have to comply with general regulatory requirements such as Registration, Labelling and GMP or food safety requirements. Detailed information about FDA requirements for food product are provided on our website.
Class I medical devices and 510 K exempt class II medical devices can be marketed without obtaining prior approval from FDA. However, compliance to FDA’s general requirements such as establishment registration and device listing is mandatory. Medical device registration and listing is one of the mandatory requirements for all types of medical devices.
Registration is not mandatory for cosmetic products. Cosmetic firms can voluntarily register their establishment and submit the formulations. Labeling compliance is one of the important requirement for cosmetic product. Cosmetics should be safe to use and should not contain any hazardous ingredients.
In order to sell prescription products in the USA, those should be approved by FDA. Whereas , over the counter (OTC ) final monograph drugs can be marketed without obtaining prior approval from FDA. Drug establishments must register their establishment and submit the drug listings. Good manufacturing practice is one of the important requirement for drugs marketed in the United States. Drug establishment registration is mandatory requirement for facilities involved in the manufacturing, processing ,packing and testing of drug.
Food contact substance such as kitchen ware are not approved by FDA , however all the food contact materials should be made from substance “Generally Recognized as Safe”. Manufacturer may choose to submit Threshold of Regulation exemption request or Food Contact Substance notification.
FDAbasics offers consulting service to comply with US FDA registration and other compliance requirements. If you have any questions please contact us.