Glossary of Terms

Special Control

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Compliance & Regulatory: MedTech

Special controls are regulatory requirements for class II devices. Class II Devices are those for which general controls alone are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance. Therefore, these devices are subject to both general and special controls.  

Special controls are usually device-specific and include:

  • Performance standards
  • Post market surveillance
  • Patient registries
  • Special labeling requirements
  • Premarket data requirements
  • Guidelines