FDA Registration or Approval? What is required ? 

US FDA Registration is required for your product ? Understanding US FDA Registration Requirements, a complete guide for US FDA compliance.

Manufacturer of Food, Drug, and Medical device requires US FDA registration for their facilities. US FDA Registration is only needed if you are planning to market your products in the USA.

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FDA registration vs. FDA approval

The term  “US FDA registration” or “FDA Registration” is often confused with the term  “FDA approval.” However, FDA approval and registration are two different regulatory requirements.

Graphical explanation of FDA Registration requirement.

FDA Registration

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    FDA registration for  Food  and Dietary Supplements

    Products like food and dietary supplements can be marketed without obtaining prior approval from the FDA.  However, you have to comply with the general regulatory requirements listed below.

    Medical Device

    Class I medical devices and 510 K exempt class II medical devices can be marketed without obtaining prior approval from the FDA. However, compliance with the FDA’s general requirements, such as establishment registration and device listing is mandatory. Medical device registration and listing is one of the mandatory requirements for all types of medical devices.

    Cosmetics

    Registration is not mandatory for cosmetic products. Cosmetic firms can voluntarily register their establishment and submit the formulations.

    Companies marketing cosmetic products should comply with the below-listed requirements.

    • The product should be safe for consumer use. 
    • The product label should comply with FDA requirements.  
    • Drug claims are not allowed for cosmetics. 
    • The product should not contain any hazardous ingredients.

    Drugs

    To commercialize prescription products in the USA, those should be approved by the FDA.

      Whereas,  over the counter (OTC ), final monograph drugs can be marketed without obtaining prior approval from the FDA. Here is the list of requirements for OTC monograph products
      • PThe product should comply with OTC final monograph requirements.
      • PDrug listing
      • PEstablishment registration
      • PCompliance with GMP requirements for manufacturing the product.

      More information about FDA compliance requirements for OTC monograph products can be found at the below link. 

      Food Contact Substance

      FDA does not approve food contact substances such as kitchenware. However, all the food contact materials should be made from the substance  “Generally Recognized as Safe.” The manufacturer may choose to submit a Threshold of Regulation exemption request or Food Contact Substance notification.

      FDAbasics offers a consulting service to comply with US FDA registration and other compliance requirements. If you have any questions, please contact us.