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Premarket Notification Requirements for Radionuclide Dose Calibrators

This guidance applies to Radionuclide Dose Calibrators (RDCs) as defined in 21 CFR 892.1360, which are Class II devices used to assay radionuclides before patient administration. It covers calibrators used in nuclear medicine and brachytherapy, including new RDCs, new components, and significant modifications affecting safety or effectiveness.

  1. Determine appropriate 510(k) submission type (Traditional, Special, or Abbreviated)
  2. Prepare comprehensive device description including detector type and system components
  3. Identify and document comparison to predicate device
  4. Conduct necessary performance testing including calibration, accuracy, and linearity
  5. Verify electromagnetic compatibility
  6. Prepare software documentation if applicable
  7. Develop complete labeling package with all required elements
  8. Prepare administrative documentation including 510(k) Summary/Statement
  9. Consider applicable standards compliance and prepare declarations of conformity
  10. Document all sources of error and their mitigation strategies

Key Considerations

Non-clinical testing

  • Initial calibration method must be described with NIST derivable calibration sources
  • Common sources of error and their magnitude must be documented
  • Activity ranges must be specified
  • Accuracy and reproducibility must be demonstrated
  • Linearity must be verified
  • Background radiation interference must be assessed

Software

  • Must follow “Guidance for Content of Premarket Submissions for Software Contained in Medical Devices”
  • Year 2000 compatibility must be addressed
  • Software functions must be described in labeling

Labelling

  • Must include summary specification sheet
  • Instructions for use must contain:
    • Indications for use
    • Contraindications, warnings, precautions
    • Calibration instructions for specific isotopes
    • Expected uncertainty for each radionuclide
    • Activity range specifications
    • Source positioning requirements
    • Maintenance schedules
    • Sources of error discussion

Safety

  • Electromagnetic compatibility must be addressed
  • Environmental factors limitations must be specified
  • Power source specifications must be provided

Other considerations

  • IEC 61303: Medical Electrical Equipment: Radionuclide calibrators – Particular methods for describing performance
  • IEC 61145: Calibration and usage of ionization chamber systems for assay of radionuclides
  • ANSI N42.13-1986: Calibration and usage of “dose Calibrator” ionization chambers for the assay of radionuclides

Original guidance

  • Premarket Notification Requirements for Radionuclide Dose Calibrators
  • HTML / PDF
  • Issue date: 1998-11-19
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: b62b4d5641b6dc479130fd0032cc8614
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