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process of listing products with the U.S. Food and Drug Administration

FDA registration refers to the process by which manufacturers and distributors of certain products, such as medical devices, pharmaceuticals, and food items, must register their facilities with the U.S. Food and Drug Administration (FDA). This registration allows the FDA to monitor and inspect these facilities to ensure compliance with safety and quality standards. It is important to note that FDA registration is not the same as FDA approval, which involves a more rigorous review process to evaluate the safety and efficacy of a product before it can be marketed.

Related Terms

• FDA clearance
• FDA compliance
• FDA regulation
• FDA approval
• Food and Drug Administration
• Regulatory Approval
• FDA Adverse Event Reporting System
• FDA-approved
• Off-label Use
• Drug Approval Process