Dual Use Molecular Diagnostic Instruments with FDA-Approved and Non-Approved Functions
This guidance applies to molecular diagnostic instruments that combine both FDA approved/cleared functions and functions that don't require approval/clearance in a single instrument. It covers instruments used with assays that measure nucleic acid analytes, including hardware, firmware, and control software. The guidance excludes instruments for blood screening, blood components screening, and blood grouping.
Recommended Actions
- Implement clear separation between approved and non-approved functions through software design
- Develop comprehensive validation procedures and documentation
- Create separate labeling materials for approved and non-approved functions
- Establish risk analysis and mitigation strategy
- Implement proper change control procedures for both approved and non-approved functions
- Set up adverse event reporting system covering all functions
- Create verification procedures for users after non-approved function usage
- Develop clear result reporting system distinguishing between function types
- Establish coordination process with third-party assay developers
- Train staff on proper promotion and labeling requirements to avoid misbranding
Key Considerations
Non-clinical testing
- Demonstrate non-interference between approved/cleared functions and functions not requiring approval/clearance
- Provide validation procedures for users to verify no interference after using non-approved functions
- Include an analyte test panel to verify proper function
Human Factors
- Consider human factors in mitigation design (clear menu options, grayed-out inapplicable options)
- Prevent user confusion between approved and non-approved functions
- Implement clear separation between functions (e.g., dual boot design)
Software
- Clearly separate approved/cleared functions from non-approved functions
- Consider dual boot design at startup
- Document all software changes in IVD change control system
- Notify FDA of changes that could affect approved functions
Labelling
- Develop separate labeling for approved/cleared functions
- Comply with 21 CFR 809.10 requirements
- Clearly distinguish between approved and non-approved functions
- Include clear indication of FDA-approved uses
- Separate result reports for approved vs non-approved functions
- Add “Not approved/cleared by FDA” in applicable result reports
Safety
- Provide risk/hazard analysis for coexistence of different functions
- Implement risk mitigation plan
- Document risk assessment for any changes
Other considerations
- Report all device-related adverse events per 21 CFR 803.10
- Coordinate with third-party assay developers for adverse event investigations
- Maintain proper documentation of instrument verification procedures
Relevant Guidances
- Content of Premarket Submissions for Device Software Functions
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Changes to Medical Device Definition for Software Functions Under the 21st Century Cures Act
Related references and norms
- 21 CFR 803.10: Medical Device Reporting
- 21 CFR 809.10: Labeling for in vitro diagnostic products
- 21 CFR 807.81(a)(3): 510(k) requirements for device modifications
- 21 CFR 814.39: PMA supplements requirements
Original guidance
This post is licensed under CC BY 4.0 by the author.