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Class II Device 510k Exemption Process and Evaluation Criteria

This guidance establishes standard operating procedures for CDRH/FDA to process exemptions of Class II medical devices from premarket notification (510(k)) requirements under Section 510(m)(2) of the FD&C Act. It outlines the petition process, evaluation criteria, and limitations for granting such exemptions.

  1. Review device against exemption criteria and limitations before pursuing exemption
  2. Prepare detailed petition addressing all factors outlined in Section III of guidance
  3. Submit petition to Dockets Management Branch with copy to CDRH Document Mail Center
  4. Clearly mark submission as “Class II 510(k) exemption petition”
  5. Include all required information per 21 CFR 10.30(b)
  6. Address why premarket notification is not necessary for safety and effectiveness
  7. Monitor 180-day review period for FDA response
  8. Be prepared to respond to FDA requests for clarification
  9. Maintain compliance with all other regulatory requirements even if exemption is granted

Key Considerations

Labelling

  • Exemptions may be subject to specific labeling requirements
  • Changes in intended use from professional to lay use may void the exemption

Safety

  • Device must not have a significant history of false or misleading claims
  • Device characteristics necessary for safe and effective performance must be well established
  • Changes that could affect safety must be readily detectable by users
  • Changes must not materially increase risk of injury, incorrect diagnosis, or ineffective treatment

Other considerations

  • 21 CFR 860.3(i): Definition of device type
  • 21 CFR 10.30: Administrative Practices and Procedures - Citizen Petition

Original guidance

  • Class II Device 510k Exemption Process and Evaluation Criteria
  • HTML / PDF
  • Issue date: 1998-02-18
  • Last changed date: 2020-02-28
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Premarket
  • ReguVirta summary file ID: b24851a6fd1bed69c548e55c2dc0ba0a
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