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.
Recommended Actions
- Review device against exemption criteria and limitations before pursuing exemption
- Prepare detailed petition addressing all factors outlined in Section III of guidance
- Submit petition to Dockets Management Branch with copy to CDRH Document Mail Center
- Clearly mark submission as “Class II 510(k) exemption petition”
- Include all required information per 21 CFR 10.30(b)
- Address why premarket notification is not necessary for safety and effectiveness
- Monitor 180-day review period for FDA response
- Be prepared to respond to FDA requests for clarification
- 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
- Device changes must not result in a change in device classification
- Different fundamental scientific technology from legally marketed devices voids the exemption
- For IVDs, specific limitations apply for certain diagnostic applications (neoplastic diseases, genetic disorders, life-threatening diseases, etc.)
- Exemption does not exempt from other regulatory requirements (e.g., GMP)
Relevant Guidances
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- MDUFA Performance Goals and Processing of 510k Submissions
- User Fees and Refunds for 510k Submissions
Related references and norms
- 21 CFR 860.3(i): Definition of device type
- 21 CFR 10.30: Administrative Practices and Procedures - Citizen Petition
Original guidance
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