In the United States, several types of businesses require FDA registration and certification, depending on the nature of their products and operations. Here’s a detailed overview:

1. Medical Device Manufacturers

Businesses involved in manufacturing, processing, packing, or holding medical devices must register their establishments with the FDA. This includes companies producing a wide range of devices from simple tools to complex machines. They must also list their devices and comply with Quality System Regulation (QSR) requirements.

2. Drug Manufacturers

Companies that produce or package prescription and over-the-counter drugs are required to register with the FDA. This includes pharmaceutical companies and contract manufacturers. They must submit a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) for their products, and adhere to Good Manufacturing Practices (GMP).

3. Biologics Manufacturers

Businesses involved in the production of biologics, such as vaccines, blood products, and gene therapies, need to obtain FDA certification. This requires submitting a Biologics License Application (BLA) and complying with FDA regulations on biologics manufacturing and safety.

4. Food and Beverage Companies

Firms that manufacture, process, pack, or hold food products must register their facilities with the FDA. This includes companies producing dietary supplements, bottled water, and other consumables. They must adhere to Food Safety Modernization Act (FSMA) requirements and proper labeling practices.

5. Dietary Supplement Manufacturers

Companies producing dietary supplements need to ensure their products comply with FDA regulations, which includes registering their facilities and following Good Manufacturing Practices (GMP) for dietary supplements. They must also ensure accurate and compliant labeling.

6. Tobacco Product Manufacturers

Businesses involved in the manufacture or importation of tobacco products must register with the FDA and comply with regulations specific to tobacco products, including premarket review and reporting requirements.

7. Cosmetic Manufacturers

While cosmetics are not premarket approved by the FDA, manufacturers must comply with labeling requirements and ensure their products are safe for use. They should also adhere to Good Manufacturing Practices.

8. Veterinary Product Manufacturers

Businesses producing veterinary drugs, medical devices, or food additives for animals must register and meet FDA regulations specific to animal health products.

In summary, any business involved in producing, processing, or distributing products regulated by the FDA needs to obtain appropriate registration and certification to ensure compliance with U.S. regulations.

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