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Is FDA Registration Mandatory in the United States?
Category：行業(yè)資訊 Date：2024-11-13 16:58:17 Author: Source:
In summary, FDA registration is required for medical devices, drugs, food products, and some other regulated products to ensure public safety. However, not all products require FDA registration—cosmetics, for instance, are not required to be registered, though they must comply with safety and labeling standards.

Yes, FDA registration is mandatory for certain products before they can be marketed or sold in the United States, but the requirements depend on the type of product.4(1).jpg

When FDA Registration is Required:

  1. Medical Devices: Manufacturers of medical devices must register their facilities and list their devices with the FDA. In addition, depending on the type of device, they may need premarket approval (PMA) or clearance (510(k)) before they can be sold in the U.S.

  2. Drugs and Biologics: Pharmaceutical companies must register their drug products and submit New Drug Applications (NDAs) or Biologics License Applications (BLAs) for approval before the drugs can be marketed in the U.S.

  3. Food Products: All food facilities involved in the manufacturing, processing, packing, or holding of food for consumption in the U.S. are required to register with the FDA. This ensures food safety and compliance with U.S. regulations.

  4. Cosmetics: While there is no mandatory FDA registration for cosmetics, manufacturers may voluntarily notify the FDA about their products, although this is not a requirement for marketing.

When FDA Registration is Not Required:

  • Non-Regulated Products: Some products, such as certain low-risk items (depending on classification), may not require FDA registration, but they must still meet other legal requirements.
  • Certain Cosmetics: Although not required, companies may choose not to register or notify the FDA, but they are still responsible for ensuring their products are safe and comply with labeling regulations.

In summary, FDA registration is required for medical devices, drugs, food products, and some other regulated products to ensure public safety. However, not all products require FDA registration—cosmetics, for instance, are not required to be registered, though they must comply with safety and labeling standards.

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