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. US FDA Registration is required only if you are planing to market your products in the USA.  The term  “US FDA registration” or “FDA Registration” is often confused with term  “FDA approval”. However, FDA approval and registration are two different  regulatory  requirements.

us fda registration

Graphical explanation of FDA Registration  requirement.

FDA Registration


  • Food  and Dietary Supplements 

Products like food and dietary supplements can be marketed without obtaining  prior approval  from FDA.  However, you have to comply with general regulatory  requirements such as  Registration, Labelling and GMP or  food safety requirements. Detailed information about FDA requirements for food product are provided  on our website. 

  • Medical Device 

Class I  medical devices and 510 K exempt class II medical devices can be marketed without obtaining prior approval from FDA. However,  compliance to  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. Labeling compliance  is one of the important requirement for cosmetic product.  Cosmetics  should be safe to use and should not contain any hazardous ingredients.

  • Drugs

In order to sell  prescription products in the USA, those  should be approved by FDA. Whereas ,  over the counter (OTC ) final monograph drugs can be marketed  without obtaining  prior approval from FDA. Drug establishments must register their establishment and submit the drug listings.  Good manufacturing  practice is one of the important requirement for drugs marketed in the United States. Drug establishment registration is mandatory requirement for facilities involved in the manufacturing, processing ,packing  and  testing  of drug.

  • Food Contact Substance 

Food contact substance such as kitchen ware are not approved by FDA , however all the food contact materials   should be made from substance  “Generally Recognized as Safe”. Manufacturer may choose to submit Threshold of Regulation exemption request or Food Contact Substance notification.

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







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