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Regulatory

FDA-approved

A drug or device authorized for medical use by the US Food and Drug Administration.

FDA approval is one of the most rigorous regulatory standards globally. Many drugs and devices used internationally are also FDA-approved, but some are approved abroad before US approval.

What this means for you: not all FDA-approved-elsewhere products are FDA-approved in the US. Confirm the specific implant or drug is the one used internationally.

General information, not medical advice

What a term means for you depends on your own reports. Ask your treating doctor, or send your reports for a free review.

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Glossary entries are written by the Medcasts editorial team in plain language and checked against current clinical and regulatory sources.

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