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Content Considerations for Superficial and Interstitial Photon-Emitting Radionuclide Brachytherapy Sources

This guidance applies to superficial and interstitial photon-emitting Radionuclide Brachytherapy Sources as defined in 21 CFR 892.5730. These are Class II devices consisting of a radionuclide enclosed in a sealed container made of gold, titanium, stainless steel, or platinum, intended for medical purposes. The guidance excludes sources intended for use in the cardiovascular system for restenosis prevention.

  1. Ensure source design meets ANSI N43.6-1997 or ISO 2919 standards
  2. Establish traceable calibration system to NIST
  3. Develop comprehensive quality system for manufacturing
  4. Prepare detailed source documentation including engineering drawings
  5. Conduct and document source output measurements and dose distribution
  6. Create complete labeling package with all required information
  7. Obtain sealed source certificate from regulatory authority
  8. Prepare verification and validation documentation if using calculation software
  9. Establish procedures for leak testing, sterilization, and disposal
  10. Document dosimetric models and parameters with independent validations

Key Considerations

Non-clinical testing

  • Source output measurements and dose distribution verification
  • Calibration system must be traceable to NIST or equivalent national standard
  • Dosimetric properties validation with at least two independent determinations
  • Isodose curves documentation from 90% to 10% of maximum dose

Software

  • If using calculational techniques (e.g., Monte Carlo), verification and validation procedures must be documented

Labelling

  • Indications for use
  • Single/multiple use specification
  • Contraindications, warnings, precautions
  • Source physical properties and dimensions
  • Shelf life
  • Implantation method
  • Sterilization methods
  • Disposal methods
  • Dosimetric properties and models
  • Source output verification procedures

Safety

  • Leak test procedures
  • Source encapsulation classification according to standards
  • Sealed source certificate from regulatory authority
  • Quality system for manufacturing specifications

Other considerations

  • ANSI N43.6-1997: Classification of Sealed Radioactive Sources
  • ISO 2919: Sealed radioactive sources—General requirements and classification

Original guidance

  • Content Considerations for Superficial and Interstitial Photon-Emitting Radionuclide Brachytherapy Sources
  • HTML / PDF
  • Issue date: 2000-08-01
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: c118d5dd73f597357f16089c55edb440
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