Manufacturer of Food, Drug, and Medical device requires US FDA registration for their facilities. US FDA Registration is only needed if you are planning to market your products in the USA.
The term “US FDA registration” or “FDA Registration” is often confused with the 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 the FDA. However, you have to comply with the general regulatory requirements listed below.
information about FDA requirements for food products can be found at this link.
Class I medical devices and 510 K exempt class II medical devices can be marketed without obtaining prior approval from the FDA. However, compliance with the 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.
Companies marketing cosmetic products should comply with the below-listed requirements.
To commercialize prescription products in the USA, those should be approved by the FDA.
Whereas, over the counter (OTC ), final monograph drugs can be marketed without obtaining prior approval from the FDA. Here is the list of requirements for OTC monograph products
More information about FDA compliance requirements for OTC monograph products can be found at the below link.
Food Contact Substance
FDA does not approve food contact substances such as kitchenware. However, all the food contact materials should be made from the substance “Generally Recognized as Safe.” The manufacturer may choose to submit a Threshold of Regulation exemption request or Food Contact Substance notification.
FDAbasics offers a consulting service to comply with US FDA registration and other compliance requirements. If you have any questions, please contact us.