What is an FDA Certificate? What Products Can Obtain FDA Certification?

An FDA certificate depends on the type of product being marketed in the United States. Not all products require an FDA certificate.

Which products require an FDA certificate?

 

FDA Certificate for Food; Food products do not require an FDA certificate, but food facilities must be registered with the FDA. The FDA Certificate is required for all domestic and foreign facilities that produce, process, package, or hold food intended for human or animal consumption in the United States.

FDA Certification for Drugs; The FDA checks whether a drug is suitable for the Over-the-counter (OTC) system. Drug products must be safe and effective. OTC establishes the conditions under which drug products are safe and effective for consumption. If a new drug does not comply with the OTC monograph, it will require certification from the FDA. Drug manufacturers conduct laboratory, human, and animal tests on their products and then submit the data to the FDA. The FDA reviews the data and issues an FDA certificate for the product.

FDA Certification for Cosmetics

Cosmetic products and ingredients (excluding color additives) do not require FDA certification before marketing. Cosmetic companies are not required to register with the FDA, but cosmetic products must be safe for consumer use. There are some situations in cosmetic labeling that may cause the FDA to regulate a cosmetic product as a drug product and, in some cases, require that the cosmetic product obtain approval from the FDA.

FDA Certification for Color Additives

Color additives used in food, drugs, certain medical devices, and cosmetics require FDA certification. There are some high-risk colors that require certification from the FDA. Color additives can only be used within the scope of FDA-approved specifications. Harmful color additives are restricted under FDA regulations.

FDA Certification for Medical Devices

Medical devices are categorized by the FDA into three risk-based categories, similar to the European Union’s CE certification. The categories are as follows: Class I, Class II, Class III. Class III medical devices are the devices with the highest risk. Class III devices require FDA approval. Class III medical device manufacturers must guarantee to the FDA that these Class III devices are safe and effective for use.

To obtain FDA certification or FDA registration, you can consult with the TESTPLUS team of experts.