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.
What You Need to Know? 👇
What are molecular diagnostic instruments with combined functions?
These are instruments that serve as components of FDA-cleared/approved IVD systems but can also be configured by users for other purposes like basic research, combining both regulated and non-regulated functions in a single device.
How does FDA evaluate instruments with both approved and non-approved functions?
FDA assesses whether sufficient measures ensure non-approved functions don’t interfere with approved functions and prevent user confusion. This includes design controls, validation procedures, risk mitigation plans, and clear labeling distinctions.
What is a dual boot design for molecular diagnostic instruments?
A dual boot design requires users to choose at startup between approved/cleared functions or non-approved functions. Users cannot switch between modes without returning to the startup screen, effectively separating software functions.
What labeling requirements apply to instruments with combined functions?
Separate labeling must be developed for approved/cleared functions only. The labeling should indicate the instrument was approved/cleared only for specific assays and must not combine approved and non-approved claims.
How should software/hardware changes be handled for combined function instruments?
All changes affecting approved/cleared functions must be reported to FDA per 21 CFR requirements. Both approved and non-approved function changes should be included in the manufacturer’s IVD change control quality system.
What MDR reporting obligations exist for combined function instruments?
Manufacturers must report all device-related adverse events under 21 CFR 803.10, including malfunctions from non-approved functions, since all instrument functions can potentially impact approved/cleared indications directly or indirectly.
What You Need to Do 👇
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