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.
Recommended Actions
- Ensure source design meets ANSI N43.6-1997 or ISO 2919 standards
- Establish traceable calibration system to NIST
- Develop comprehensive quality system for manufacturing
- Prepare detailed source documentation including engineering drawings
- Conduct and document source output measurements and dose distribution
- Create complete labeling package with all required information
- Obtain sealed source certificate from regulatory authority
- Prepare verification and validation documentation if using calculation software
- Establish procedures for leak testing, sterilization, and disposal
- 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
- Source material information including radionuclide identification and properties
- Source design and encapsulation details
- Manufacturing process information
Relevant Guidances
- Content of Premarket Submissions for Device Software Functions
- Software Validation for Medical Device Production, Quality Systems, and Device Components
- Unique Device Identifier (UDI) Form and Content Requirements
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Submission Requirements for Terminally Sterilized Medical Devices
Related references and norms
- ANSI N43.6-1997: Classification of Sealed Radioactive Sources
- ISO 2919: Sealed radioactive sources—General requirements and classification
Original guidance
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