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Home » Modified 510(k) Devices Not Eligible for Custom Device Exemption: U.S. FDA
Modified 510(k) Devices Not Eligible for Custom Device Exemption: U.S. FDA
The U.S. Food and Drug Administration’s new custom device exemption does not apply to 510(k)-cleared devices that are modified but still retain their original intended use and could be clinically studied, the agency clarifies in a draft guidance.
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