Technical Performance Assessment and Premarket Requirements for Digital Diagnostic Radiology Display Devices
This guidance applies to display devices intended for diagnostic radiology classified under 21 CFR 892.2050 (product code PGY). These devices are class II devices intended to be used in controlled viewing conditions to display and view digital images for primary image interpretation. The guidance does not apply to real-time displays part of image acquisition devices, medical image hardcopy devices, imaging software applications, ophthalmic image management systems, displays for whole-slide imaging, or displays in handheld/mobile devices.
Recommended Actions
- Determine if device falls within scope of guidance
- Prepare comprehensive device description with side-by-side predicate comparison
- Conduct all required physical laboratory testing based on intended use
- Prepare software documentation at Basic Documentation Level
- Ensure electrical safety testing compliance
- Develop quality control procedures and manual
- Create comprehensive labeling including all required elements
- Consider submitting pre-submission if device includes novel features
- For device modifications, evaluate need for new 510(k) using appropriate guidance
- Consider bundling multiple display models in single submission if making same modifications
Key Considerations
Non-clinical testing
- Physical laboratory testing required including:
- Spatial resolution
- Pixel defects
- Artifacts
- Temporal response
- Luminance measurements
- Grayscale-to-luminance function conformance
- Additional tests for mammography displays (luminance uniformity, stability, spatial noise, etc.)
- Color tracking and gray tracking for color displays
Software
- Documentation level should be “Basic” for display devices
- Software documentation required for:
- Display controls
- Ambient light sensing
- Luminance calibration tools
- Quality-control software
Cybersecurity
- Must follow cybersecurity guidance for networked medical devices containing off-the-shelf software
- Must address cybersecurity in premarket submissions
Labelling
- Must include prescription use statement
- Clear instructions for use
- Quality assurance processes
- Maintenance schedule
- Calibration procedures
- Special statement for mammography displays regarding lossy compression
Safety
- Electrical safety testing according to ANSI/AAMI ES60601-1
- Declaration of Conformity to FDA-recognized consensus standards acceptable
Other considerations
- Device description must include detailed technical specifications
- Side-by-side comparison with predicate device required
- Quality control procedures must be described
Relevant Guidances
- Content of Premarket Submissions for Device Software Functions
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Deciding When to Submit a New 510k for Changes to an Existing Medical Device
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
Related references and norms
- ANSI/AAMI ES60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- NEMA XR 22: Quality Control Manual Template for Manufacturers of Displays and Workstations
- IEC 62536-1: Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
- ISO/CIE 11664-5: Colorimetry - Part 5: CIE 1976 Luv* colour space
Original guidance
- Technical Performance Assessment and Premarket Requirements for Digital Diagnostic Radiology Display Devices
- HTML / PDF
- Issue date: 2022-09-28
- Last changed date: 2022-09-27
- Status: FINAL
- Official FDA topics: Radiation-Emitting Products, Medical Devices, 510(k), Labeling, Premarket, Radiological Health, Radiology
- ReguVirta summary file ID: 06e94a1e30405aefd49b50d92dbd15cd
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