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What is the Regulatory Authority for Medical Devices in the United States?
Category：企業(yè)動態(tài) Date：2024-12-12 17:18:47 Author: Source:
The regulatory authority for medical devices in the United States is the Food and Drug Administration (FDA). The FDA is responsible for ensuring the safety, effectiveness, and quality of medical devices sold in the U.S. through regulations, oversight, and approval processes, including premarket submissions (such as 510(k) or PMA), establishment registration, and post-market surveillance.

The regulatory authority for medical devices in the United States is the Food and Drug Administration (FDA). The FDA is responsible for ensuring the safety, effectiveness, and quality of medical devices sold in the U.S. through regulations, oversight, and approval processes, including premarket submissions (such as 510(k) or PMA), establishment registration, and post-market surveillance.

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