Custom Device Exemption Requirements and Implementation
This guidance provides clarification on the implementation of the custom device exemption contained in Section 520(b) of the FD&C Act. It explains how FDA interprets the 5 units per year limitation, defines key terms, describes annual reporting requirements, and provides examples of what may or may not qualify as a custom device.
Recommended Actions
- Determine if device meets all custom device exemption criteria:
- Treats sufficiently rare condition
- Clinical trials impractical
- Limited to 5 units per year
- Not generally available
- No other device available domestically
- Implement proper labeling requirements
- Maintain quality system compliance
- Establish process for annual reporting to FDA including:
- Cover letter
- Truthful and accurate statement
- Summary of devices shipped/used/returned
- Patient/physician information as applicable
- Device details
- Track number of units manufactured per year to ensure compliance with 5-unit limit
- Document justification for custom device qualification
- Maintain records of physician orders and unique patient/physician needs
- Submit annual reports within first quarter of following calendar year
Key Considerations
Clinical testing
- Clinical investigations must be impractical due to the rarity of the condition being treated
- Device must be for treating a sufficiently rare condition that makes clinical trials impractical
Labelling
- Must include:
- Statement that it is a custom device
- Name of ordering physician
- Patient identifying information (if applicable)
- Indications for use
- Sterilization status
- Composition information
- Storage conditions
Safety
- Not exempt from Quality System Regulation requirements
- Not exempt from Medical Device Reporting requirements
- Not exempt from Corrections and Removals requirements
Other considerations
- Limited to 5 units per year of a particular device type
- Must be created/modified to comply with physician order
- Cannot be generally available in finished form through labeling/advertising
- Must be designed to treat unique pathology/physiological condition
- No other device domestically available to treat the condition
- Must be manufactured on case-by-case basis
- Annual reporting to FDA required
Relevant Guidances
- Quality System Information Requirements for Premarket Submissions
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Unique Device Identifier (UDI) Form and Content Requirements
- Labeling Requirements and Recommendations for Medical Devices
Related references and norms
- 21 CFR Part 820: Quality System Regulation
- 21 CFR Part 803: Medical Device Reporting
- 21 CFR Part 801: Labeling
- 21 CFR Part 806: Corrections and Removals
- 21 CFR Part 807: Registration and Listing
Original guidance
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