What are the FDA labeling requirements medical devices must meet for regulatory compliance? (Health & Beauty - Health Services)

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What are the FDA labeling requirements medical devices must meet for regulatory compliance?


FDA labeling requirements for medical devices mandate accurate information on device identity, intended use, warnings, instructions, and manufacturer details. Labels must comply with 21 CFR Part 801, be legible, prominently displayed, and may include symbols as per ISO standards. Compliance ensures safety, effectiveness, and adherence to regulatory standards for market approval.

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Last Update : Jul 25, 2025 7:31 AM
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2025-09-05 (0.222 sec)