How to get FDA certification - FDA approval

US FDA regulate a wide range of products including food, medical device, drug, and cosmetics. FDA use different measures to make sure the quality of products marketed in the USA. The US FDA requirements for each product category are different.

FDA Certification or FDA approval is not required for food products, FDA bio-terrorism registration (also referred as FDA food facility registration) is mandatory requirement for food establishments.

Medical device establishments require FDA registration, if the device is not 510k exempted each device require FDA clearance or FDA approval depends on FDA device classification.

FDA approval is mandatory requirement for new drugs, FDA approve drug products only after strict evaluation of documents, test results, clinical studies, protocol, and site inspection. Drug products in OTC Monograph does not require FDA approval.

FDA registration for cosmetic products is not mandatory, FDA does not certify or approve cosmetic products.

FDA batch certification is required for certain color additives. FDA review the sample of each lot of color additive manufactured and certify if it complies with requirement.

For more information about how to get FDA certification or FDA approval please contact us at info@fdahelp.us


FDA Registration links

 

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