What Does ‘FDA Approved’ Mean?
"FDA approved" means that the agency has determined that the "benefits of the product outweigh the known risks for the intended use." Manufacturers must submit a premarket approval (PMA) application and the results of clinical testing in order to get approval. If the FDA determines the research, data, and evidence show the drug is safe and effective for the intended use, it approves the drug. Once approved, the FDA continues monitoring the drug’s safety, effectiveness, and quality. The process can take years; it shows the FDA’s commitment to protecting patients.
FDA Approval Requirements
"FDA approved" means the agency determined the "benefits of the product outweigh the known risks for the intended use." Manufacturers must submit a premarket approval application and clinical testing results to get approval. If research, data, and evidence show the drug is safe and effective for intended use, the FDA approves it. Once approved, the FDA monitors the drug’s safety, effectiveness, and quality. The process can take years, showing the FDA’s commitment to protecting patients.
FDA Approval Processes
The processes for “FDA Cleared” and “FDA Approved” vary based on the product and classification. Only lower-risk medical devices (Class I and II) are cleared by the FDA, if not exempt by law. Examples of products requiring FDA approval include new drugs with new chemical formulas or existing formulas prescribed for different uses. The FDA follows a strict approval process for products under its jurisdiction to ensure safety. Understanding the implications of FDA approval is crucial when making decisions about products we use daily.