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Glossary Term
FDA (Food & Drug Administration)
Definition
The FDA (Food and Drug Administration) is a U.S. federal agency under the Department of Health and Human Services (HHS) responsible for protecting public health by regulating the safety, efficacy, and security of medical devices, drugs, biologics, food, cosmetics, and other products. In the MedTech industry, the FDA oversees the approval, clearance, and surveillance of medical devices to ensure they meet established regulatory standards.
Relevance to the MedTech Industry
The FDA ensures that medical devices introduced into the U.S. market are safe, effective, and manufactured in compliance with regulatory requirements. It provides pathways for market access, enforces quality systems, and monitors post-market device performance to protect patients and foster innovation.
Additional Information & Related Terms
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