← All terms
CATEGORY: CLASSIFICATION
Class III Medical Device
The highest risk category of medical devices in the US, requiring PMA approval. Class III devices sustain or support life, are implanted, or present potential unreasonable risk. Examples include pacemakers, heart valves, and drug-eluting stents.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
Class III is the highest US risk class—usually PMA—covering life-supporting/implantable or high-risk devices.
PROCESS / STEPS
- Confirm Class III status early in development.
- Plan clinical evidence and manufacturing controls.
- Execute PMA strategy and post-approval commitments.
EXAMPLES
- Pacemakers and many high-risk implants are Class III.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Class III Medical Device across 27 authorities in real time.
START FREE →