There are distinct FDA registration and FDA certification requirements. Registration is necessary for FDA-regulated items such as dietary supplements and medical equipment. Although FDA approval of nutritional claims on the label is necessary (e.g., “gluten-free,” “fat-free,” or “natural”), FDA certification is not required. FDA Registration and FDA Certification are two methods for ensuring that a company’s goods comply with FDA regulations.
Before you may apply for FDA certification, you must first register with the agency. The FDA registration of your company confirms that it conforms with FDA standards and regulations. It certifies that your products are legal to sell in the United States. This approach is required for FDA certification regardless of the number of goods manufactured.