Companies that need to obtain FDA registration and certification typically include:

1. Medical Device Manufacturers

• Producers of Medical Devices: Companies that manufacture, prepare, or import medical devices for use in the U.S. need to register with the FDA and may require certification depending on the device class.

2. Drug Manufacturers

• Pharmaceutical Companies: Entities involved in the production and distribution of prescription or over-the-counter drugs must register with the FDA and comply with regulatory requirements.

3. Biologics Manufacturers

• Biotechnology Companies: Firms producing biologics, such as vaccines, blood products, or gene therapies, must be registered and meet FDA standards for safety and efficacy.

4. Food Manufacturers

• Food Processing Companies: Businesses involved in the production of food products, including dietary supplements and additives, need to comply with FDA regulations, though not all may require formal registration.

5. Cosmetic Manufacturers

• Cosmetics and Personal Care Products: Companies producing cosmetics and personal care products must adhere to FDA regulations, though registration is generally not required unless the product makes therapeutic claims.

6. Contract Manufacturers

• Outsourced Production: Companies that manufacture products under contract for other businesses must also comply with FDA regulations if the products fall under FDA jurisdiction.

7. Importers and Distributors

• Import and Distribution Entities: Companies that import or distribute medical devices, drugs, or biologics in the U.S. must be registered with the FDA and ensure that their products meet FDA standards.

These companies must meet specific FDA requirements and obtain registration or certification depending on the nature of their products and activities.