What we usually call FDA certification mainly refers to FDA Registration (FDA Registration).FDA registration is mainly for the following product categories.
FDA Registration/Certification:
1. Food FDA Registration.
The Bioterrorism Act requires all U.S. and non-U.S. businesses engaged in the manufacture, processing, packaging, or storage of food, beverages, or dietary supplements that will be consumed in the United States to register with the U.S. Food and Drug Administration (FDA). In addition, non-U.S. food businesses must designate a U.S. legal agent to liaise with the FDA.
Food products include human food, pet food, functional food, and food additives.
2. Medical device FDA registration.
The U.S. Food and Drug Administration (FDA) Modernization Act requires all companies engaged in the manufacture, formulation, dissemination, synthesis, assembly, processing, or import or export of medical devices to register and list their products with the FDA. In addition, non-U.S. companies must submit to the FDA the name, address, and telephone number of a U.S. agent who will liaise with the FDA.
The FDA's classification of medical devices is based on function, and the following household products are also classified as medical devices by the FDA: toothbrushes (manual and electric), eyeglasses, sanitary napkins, adult diapers, scales, facial massagers, and noise-canceling headphones.
3. Drugs FDA registration.
All drug manufacturers that produce drugs intended for use in the diagnosis, treatment, symptomatic relief, management, or prevention of disease that have pharmacological activity or other direct effects, or that can affect the function and structure of the body, are required to register and declare all of their ingredients with the FDA. All non-U.S. facilities exporting drugs to the U.S. must register their facilities with the FDA and declare their products.
The main categories of drugs are:
(1) For humans:
Prescription drugs
Over-the-counter (OTC)
Active Pharmaceutical Ingredients (API)
Homeopathic medicines
Medical gases
(2) For animals (Veterinary drugs):
Prescription and over-the-counter medicines
Medicated animal feed
Easily overlooked products belonging to the pharmaceutical category: sunscreen, whitening, wrinkle-reducing and anti-acne masks, anti-dandruff shampoos, fluoride toothpaste, leave-on antiseptic hand sanitizers, disinfectant wipes, and so on.
4. FDA registration of radiation-emitting electronic products.
The U.S. FDA defines a radiation-emitting electronic product as "any product that contains electronic circuits that emit radiation, i.e., electronic products that emit radiation". The term "radiated electronic product" refers to any product manufactured or assembled to contain electronic circuitry that emits electronic radiation when it is in operation (or emits in the absence of effective shielding, or other controls), or any component, part, or accessory that generates radiation within such a product. The term "electronic product radiation" means any ionizing or non-ionizing, electromagnetic, or particulate radiation, or any acoustic, infrasound, or ultrasonic wave emitted as a result of the operation of circuitry in an electronic product.
According to the requirements of Chapter 531 of the U.S. FD&C Act, manufacturers, importers, wholesalers, and distributors of any electronically emitted product are required to submit a report to the FDA. Product reports or abbreviated product reports must be submitted to the FDA prior to marketing. Annual reports are due to the FDA on September 1 of each year and are required to cover a 12-month period from the last report end date (June 30th). Non-U.S. companies must designate a U.S. agent to liaise with the FDA.
5. Cosmetics FDA
According to the U.S. FDA's newly enacted MoCRA "Cosmetics Regulations Modernization Act of 2022" new regulations require that: cosmetic exports to the U.S. must be required to apply for the FDA certification/registration of the relevant specific requirements are as follows:
One of the requirements of the FDA regulations
.According to the U.S. FDA on December 29, 2022, signed by U.S. President Joe Biden through the "Modernization of Cosmetic Regulations Act of 2022" (MoCRA) provides that: all exports to the U.S. cosmetic products need to be FDA registered / certified
Second, how to do? Information?
Cosmetics FDA registration is divided into: business registration and product registration.
(1) business registration: enter the FDA cosmetics online creation system, the declaration of the company's information, the declaration is completed by the FDA manual review can be assigned to the code.
(2) product registration: then your company can submit product declarations in this account. When a product is manufactured by company A and distributed by company B, either A or B can submit a product declaration, and it is not necessary for AB to submit all of them.
Want to know more about the FDA certification of related information, recommended consulting the United States FDAREGISTRAR Shenzhen Representative Office of the Registrar Corp.