FDA Certification

Kosher Certification

About FDA

The Food and Drug Administration (FDA) was set up in order to protect the public against harmful foods, medicinal products, and cosmetics. It is an agency of the US government that provides preventive control over food safety and health claims made on medicines, drugs, medical devices, and other consumer products.

The FDA has the authority to approve any new drug or food additive before it can be marketed, monitor ingredients in foods and drugs, make sure that labeling of such products is accurate and truthful, protect the safety of the nation’s food supply, and monitor drugs for safety.

What is 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. However, they can participate in the VCRP (Voluntary Cosmetic Registration Program) of the FDA.

Who Can Apply for FDA Certification?

Food facilities, pharmaceutical firms, dietary supplement companies, and medical device companies can all apply for FDA certification. Manufacturers must first register with the FDA before selling medical equipment or drugs in the United States. Cosmetics manufacturers can register with the FDA, but it is not required.

To sell your items in the United States, you must first register. Food items do not require FDA certification; however, food makers must have FDA certification. In addition, the FDA must approve novel medications and nutritional supplements. Before accepting a product for FDA certification, the Food and Drug Administration (FDA) looks at the following factors:

  1. Inspections of the site, inspections of the procedures, and the performance of the relevant processes.
  2. There are clinical trials, test findings, study articles, and research approaches available.

FDA Certification vs. FDA Registration

FDA registration and certification are two separate processes. FDA-regulated products, such as nutritional supplements and medical equipment, need registration. Although nutritional statements on the label must be approved by the FDA (for example, “gluten-free,” “fat-free,” or “natural”), FDA certification is not needed. FDA Registration and FDA Certification are two ways to ensure that a company’s products are compliant with FDA rules.

You must first register with the FDA before you can seek certification. Your company’s FDA registration certifies that it complies with FDA requirements and regulations. It verifies that selling your items in the United States is lawful. Regardless of the number of items produced, this technique is essential for FDA certification. IAS can help your company obtain an FDA registration number.

How to Achieve FDA Registration

Obtaining an FDA registration number is one of the most important requirements for companies looking to commercialize their products in the United States. Despite the fact that FDA approval is required, medications and medical devices do not need to be registered with the FDA. It’s a one-of-a-kind registration number that confirms the company’s registration with the FDA in the United States. It does not mean that the firm or product has been approved by the FDA.

The FDA does not provide registration certificates. IAS will help you gain FDA approval for your business. We supply you with a registration certificate that reads as follows:

  • The FDA registration procedure has successfully completed.
  • The FDA has given their approval to your company.
  • Your FDA registration number is valid and can be used to sell your product.

FDA Certification Procedure Through IAS:

  1. Choose whether you want a single product with several FDA certificates or a single product with multiple certifications.
  2. Please contact us with the completed Application form to discuss the details of FDA certification.
  3. The original documentation is submitted by the maker or merchant (Based on FDA Certification standard, including test certificates)
  4. Check the documents to see if they meet the legal standards.
  5. Confirm that the product meets FDA certification criteria by conducting an audit.
  6. The final paperwork, as well as any further clarifications, must be sent.
  7. After that, the document is evaluated and approved.
  8. A compliance certificate will be awarded.

For more information on FDA Certification, please contact us at [email protected]