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Fundamentals of FDA Registration

The Food and Drug Administration (FDA) of the United States regulates a wide range of products in addition to food and drugs. Though food may be the biggest, the FDA also regulates cosmetics, dietary supplements, homeopathic remedies, medical equipment, tobacco products, vaccines, blood and biologics, animal and veterinary foods, medications and supplements, and radiation-emitting products. Hence, it encompasses much more than its name may suggest.

A fundamental requirement for selling FDA-regulated products is to ensure that they are properly approved and identified with the FDA. Food facilities are required to renew their FDA registration daily, and any medical device or pharmacy facility must be approved and registered annually, according to the FDA. It is a common misconception that simply filling out a few forms entitles you to be enrolled and classified. The FDA uses online resources for these submissions. These systems necessitate a massive amount of technical review, as well as special specifics or formats, to accept demands.

The kinds of facilities that must be registered in the supply chain vary depending on the commodity. Depending on the retail arrangement or where the supply chain is located, you can need to authorize each particular facility. As a general rule, the producer and distributor of any FDA-regulated substance must be approved by the FDA and, in some cases, apply a list of each item.

In the next few blogs, we’ll be delving deeper into some of the industries that need to register with the FDA. Please contact us should there be any questions.

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