Serious Adverse Health Consequences [Food and Drugs] Law and Legal Definition

Pursuant to 21 CFR 821.3 (e) [Title 21 Food and Drugs; Chapter I Food and Drug Administration, Department of Health and Human Services; Subchapter H Medical Devices; Part 821 Medical Device Tracking Requirements; Subpart A General Provisions], the term Serious Adverse Health Consequences means “any significant adverse experience related to a device, including device-related events which are life-threatening or which involve permanent or long-term injuries or illnesses.”