About US FDA Certification

FDA Certification is a must for the manufacturers of food, drug, or medical devices in the USA. It is a fundamental requirement for domestic and foreign establishments to market their products in the United States. Establishments that manufacture cosmetics do not need FDA registration mandatorily. But they can participate in the VCRP (Voluntary Cosmetic Registration Program) of the FDA.

FDA Certification

How to get an FDA Registration number?

FDA registration number is one of the primary requirements for the manufacturers to sell their products in the USA. Although FDA certification is a must for drugs and medical devices, the FDA registration number is not mandatory. It is a unique registration number that describes that the establishment is registered with the US FDA. It does not prove that the establishment or product got approval by the FDA. This number is for the manufacturers not for the specific products. So, you can’t label the FDA registration number on your products.

FDA does not issue the FDA registration certificate. IAS will help you get the FDA registration for your company. The registration certificate we issue establishes that:

  • The registration process is successfully completed
  • Your company registration with FDA
  • Also, your registration number is valid

Who can apply?

Food facilities, manufacturing companies of drugs, dietary supplements, and medical devices can get FDA registration. The manufacturers who want to market their products such as medical devices and drugs in the USA should register with the FDA. Also, manufacturers of cosmetics can get FDA registration. But the FDA certification is not a compulsory requirement to sell cosmetics products in the USA..

Registration is an important requirement to market your products in the USA. FDA Certification is not for food products. But, it is required for food manufacturing companies. In addition, FDA approval is mandatory for new drug and dietary supplement products. To approve a product, FDA evaluates:.

  • Mandatory documents, Test results, Clinical studies as well as Protocol
  • Also, it includes site inspection and necessary process

How to Apply

  • Finalize the product for which you need to obtain certification like different products or same product with range to be certified
  • Contact us with the completed Application form to discuss about the details of certification.
  • Submission of first documentation by manufacturer/trader (Based on Certification standard, including test certificates)
  • Ensure that the documentation fulfill the compliance requirement.
  • Audit the product to ensure the product meets the standard requirements.
  • Submission of final documentation along with additional clarifications.
  • Final document evaluation and recommendation.
  • Award of certification of Compliance.