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.
What You Need to Know? 👇
What are the key factors FDA considers when evaluating Class II device exemptions from 510(k) requirements?
FDA considers four main factors: (1) no significant history of false claims or inherent risks, (2) well-established device characteristics for safe performance, (3) changes readily detectable by users or not materially increasing risk, and (4) changes unlikely to affect device classification.
How long does FDA have to respond to a Class II device exemption petition?
FDA has 180 days to respond to a petition. If FDA doesn’t respond within this timeframe, the exemption becomes effective by operation of statute. FDA must also publish a Federal Register notice within 120 days of the initial comment request.
What happens if I want to modify my exemption petition after submission?
If you submit additional information to amend your petition, FDA generally considers it a new petition, which restarts the 180-day review clock. However, FDA may request clarification during review without restarting the timeline.
Are there limitations on Class II device exemptions from premarket notification?
Yes, exemptions don’t apply to devices with different intended uses, different fundamental scientific technology, or certain in vitro diagnostic devices for life-threatening diseases, genetic disorders, or point-of-care testing. Other regulatory requirements still apply.
Where should I submit a Class II device exemption petition?
Submit petitions to FDA’s Dockets Management Branch (HFA-305) at 12420 Parklawn Drive, Rockville, MD 20857. Also send a copy to CDRH’s Document Mail Center (HFZ-401). Mark envelopes clearly as “Class II 510(k) exemption petition.”
What information must be included in a Class II device exemption petition?
The petition must include device classification name, regulation number, petitioner contact information, and clear justification addressing why premarket notification isn’t necessary for safety and effectiveness. Specifically address the four FDA evaluation factors outlined in the guidance.
What You Need to Do 👇
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