FDA DOCUMENTATION FOR AMAZON

The term "FDA Certificate" on Amazon can have two different meanings, depending on the type of product you want to sell:

1. FDA Approval/Clearance

This applies to products that are strictly regulated by the FDA, such as:

• Drugs

• Medical devices

• Biological products

To sell these products on Amazon (or anywhere in the U.S.), FDA market approval or clearance is required:

• FDA Approval: A long and costly process requiring extensive clinical data and scientific evidence proving the product's safety and effectiveness.

• FDA Clearance (510(k)): For new medical devices, a manufacturer can obtain clearance by proving the product is substantially equivalent to an already legally marketed device.

  
  

2. FDA Registration

For products regulated by the FDA but not requiring prior market approval, such as:

• Food products

• Dietary supplements

• Cosmetics

• Radiation-emitting electronic devices

Companies involved in the manufacturing, processing, packaging, or storing of these products must register their facilities with the FDA.

🔹 Important Notes:

• FDA registration is NOT an approval process; it only informs the FDA of a facility’s existence and operations.

• For dietary supplements with new dietary ingredients (NDI), manufacturers must notify the FDA 75 days before selling the product.
  
  

Amazon & FDA Compliance

Amazon ensures that all products sold on its platform comply with applicable laws, including FDA regulations.

• Product Listing: Amazon may ask whether a product requires FDA approval or clearance and request supporting documents.

• Compliance Checks: Amazon can audit sellers for FDA compliance and remove non-compliant products.

• Seller Responsibility: Sellers must ensure their products meet FDA requirements and complete any necessary approvals, clearances, or registrations before listing on Amazon.
  
  

For assistance with FDA compliance, feel free to contact us! 🚀

Which Products Require Which FDA Compliance Measures?

✅ Drugs & Biological Products:

• FDA premarket approval (PMA) is required before sale.
  
  

✅ Medical Devices:

• Depending on the risk classification, products may require:

  • FDA Premarket Approval (PMA) for high-risk devices.

  • 510(k) Clearance for devices substantially equivalent to an already approved product.
    
    

✅ Food Products:

• Food processing facilities must register with the FDA.
  
  

✅ Dietary Supplements:

• Manufacturing and packaging facilities must be registered with the FDA.

• New dietary ingredients (NDI) require a notification at least 75 days before sale.

• Products must comply with DSHEA (Dietary Supplement Health and Education Act) and GMP (Good Manufacturing Practices).
  
  

✅ Cosmetic Products:

• FDA registration is recommended but not mandatory for manufacturers.

• Products must be safe and properly labeled.
  
  

✅ Radiation-Emitting Electronic Products:

• Manufacturers must register with the FDA.

• Products must comply with specific performance standards.
  
  

For assistance with FDA compliance for your products, feel free to reach out! 🚀