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.
What You Need to Know? 👇
What is the FDA Custom Device Exemption and when can it be used?
The Custom Device Exemption under Section 520(b) of the FD&C Act allows certain devices to bypass PMA requirements and performance standards. It applies to devices treating unique pathology/physiology or physician special needs, limited to 5 units per device type annually, with mandatory annual reporting.
Are custom devices exempt from all FDA regulatory requirements?
No. Custom devices are only exempt from PMA requirements and performance standards. They must still comply with Quality System Regulation, Medical Device Reporting, labeling requirements, corrections and removals, and registration and listing requirements under 21 CFR Parts 803, 801, 806, 807, and 820.
Can a single custom device address both patient-specific and physician-specific needs?
No. A custom device must be either patient-centric (treating unique pathology/physiology) or physician-centric (meeting special practice needs), but cannot be both. The device classification determines reporting requirements and stays with either the patient or physician’s practice accordingly.
How does the “5 units per year” limitation work for custom devices?
The limitation applies to 5 new cases per device type annually. Extra units for sizing concerns don’t count if unused devices are returned to manufacturer or destroyed. Multiple devices for bilateral conditions count as one unit if ordered together and unused devices are properly handled.
What annual reporting requirements apply to custom device manufacturers?
Manufacturers must submit annual reports by March 31 covering the previous calendar year. Reports must include device justification, patient/physician information, device details, and tracking of shipped, used, returned, and destroyed units. The first report covers from July 9, 2012 through the first reporting period.
Can modifications to existing 510(k)-cleared devices qualify as custom devices?
Generally no, unless the modification treats unique pathology/physiology making clinical studies impractical. Most modifications should follow 21 CFR 807.81 guidance. Patient-specific devices with cleared specification ranges are not custom devices, even though they’re individually tailored to patients within approved parameters.
What You Need to Do 👇
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 đź”—
- 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 đź“‚
- 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