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FDA

510(k) Approval Process

What’s The FDA’s 510(k) Approval Process and How Does It Hurt Patients?

Most people believe that any medical device available on the market goes through a thorough and effective approval process. The truth is, this is not always the case. The U.S. Food and Drug Administration (FDA) is charged with analyzing new device applications and granting approval to reasonably safe devices; however, the agency has more than one avenue for approval. In addition to the ordinary application process, the FDA has an approval process called 510(k) approval and it’s putting many patients at risk.

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Dax F. Garza
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