All terms
Special Controls
Device-type-specific FDA requirements (often performance standards, labeling, or post-market surveillance) that apply on top of General Controls.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
Special Controls are mandatory for Class II devices and are usually documented in a device-specific classification regulation or Special Controls guidance. They commonly require specific bench testing, biocompatibility, software documentation levels, or labeling statements.What this means in practice
Mapping a 510(k) to its product code's Special Controls early prevents late-stage scope surprises and forms the basis of the testing plan.Primary references
3 sourcesLink health: 2 verified 1 bot-blocked· last checked 2026-05-09
FDA·1IMDRF·1RAPS·1
- 1
FDA Special ControlsBot-blockedFDAfda.gov
- 2
IMDRF DocumentsVerifiedIMDRFimdrf.org
- 3
RAPS Regulatory FocusVerifiedRAPSraps.org
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