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Are There Device-Specific Labeling Requirements Under 21 CFR Part 801 for Special Medical Devices?

Are There Device-Specific Labeling Requirements Under 21 CFR Part 801 for Special Medical Devices?

Medical device labeling in the United States is governed by stringent FDA regulations to ensure patient safety, proper usage, and regulatory transparency. One of the most critical frameworks is 21 CFR Part 801 device-specific labeling, which outlines general and special labeling requirements for medical devices. FDA defines label as: display of written, printed, or graphic [...]The post Are There Device-Specific Labeling Requirements Under 21 CFR Part 801 for Special Medical Devices? appeared first on TechBullion.

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