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21 CFR 820

Meaning

21 CFR 820 is the specific regulatory code within the U.S. Food and Drug Administration’s (FDA) Quality System Regulation (QSR) that mandates current good manufacturing practices for medical devices. In the context of hormonal health, this applies directly to diagnostic devices, such as hormone monitoring systems, and any physical or software-based therapeutic delivery devices. Compliance ensures that these critical tools are consistently safe, effective, and meet stringent quality standards throughout their entire lifecycle.