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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.

  1. 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
  2. Implement proper labeling requirements
  3. Maintain quality system compliance
  4. 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
  5. Track number of units manufactured per year to ensure compliance with 5-unit limit
  6. Document justification for custom device qualification
  7. Maintain records of physician orders and unique patient/physician needs
  8. 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

  • 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

  • Custom Device Exemption Requirements and Implementation
  • HTML / PDF
  • Issue date: 2014-09-24
  • Last changed date: 2019-02-21
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 8eb8f61873dd55804a94e2864df9f08e
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