Marketing Clearance Requirements for Diagnostic Ultrasound Systems and Transducers
This guidance provides detailed recommendations for 510(k) submissions for diagnostic ultrasound systems and transducers. It covers: - Diagnostic ultrasound devices in radiology, cardiovascular, and obstetrics/gynecology applications - Requirements for acoustic output, safety features, and labeling - Two regulatory approaches: Track 1 (without Output Display Standard) and Track 3 (with Output Display Standard) - Modifications to legally marketed devices that may not require new 510(k)
Recommended Actions
- Determine appropriate regulatory track (Track 1 or 3) based on device features
- Implement and validate:
- Acoustic output measurements and controls
- Safety features and alarms
- Cleaning/disinfection procedures
- Software verification and validation
- Quality control procedures
- Prepare documentation:
- Complete device description
- Test reports and validation data
- Risk analysis
- Labeling and user materials
- Software documentation
- Develop:
- User training materials
- Quality control procedures
- Service procedures
- Record keeping systems
- Establish ongoing:
- Production testing protocols
- Statistical quality control
- Complaint handling procedures
- Post-market surveillance
- Submit:
- 510(k) with complete documentation
- Responses to any FDA questions
- Updates for significant changes
Key Considerations
Non-clinical testing
- Acoustic output measurements and validation
- Measurement of mechanical and thermal indices
- Statistical analysis of measurement data
- Validation of cleaning, disinfection and sterilization procedures
- Electrical safety testing according to standards
Human Factors
- Implementation of user interface features for acoustic output display and control
- ALARA education program for clinical end-users
- Clear instructions for use and warnings in labeling
Software
- Software documentation based on Level of Concern
- Validation of software changes
- Cybersecurity considerations for networked devices
- Documentation for off-the-shelf software
Cybersecurity
- Information on cybersecurity aspects for networked devices
- Compliance with FDA cybersecurity guidance
- Special considerations for devices with off-the-shelf software
Labeling
- Indications for use statement
- Warnings and precautions
- Acoustic output information
- Cleaning/disinfection instructions
- Clinical applications and limitations
- User manual with complete operating instructions
Biocompatibility
- Evaluation of patient-contacting materials
- Documentation of material composition
- Testing according to ISO 10993-1
- Validation data for reprocessed devices
Safety
- Electrical safety testing to IEC 60601-1
- Electromagnetic compatibility testing
- Temperature limits for invasive probes
- Protection against excessive acoustic output
- Transducer element integrity checks
Other considerations
- Quality control procedures
- Statistical sampling plans
- Record keeping requirements
- Reprocessing validation for reusable devices
- Special requirements for remanufactured devices
Relevant Guidances
- Content of Premarket Submissions for Device Software Functions
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
Related references and norms
- IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: Medical electrical equipment - Part 1-2: EMC requirements and tests
- IEC 60601-2-37: Medical electrical equipment - Part 2-37: Requirements for ultrasonic medical diagnostic equipment
- IEC 62359: Ultrasonics - Field characterization - Test methods for thermal and mechanical indices
- ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing
Original guidance
- Marketing Clearance Requirements for Diagnostic Ultrasound Systems and Transducers
- HTML / PDF
- Issue date: 2023-02-21
- Last changed date: 2023-02-21
- Status: FINAL
- Official FDA topics: Radiation-Emitting Products, Medical Devices, 510(k), Premarket, Radiological Health, Radiology
- ReguVirta summary file ID: b5c681772f229950f1618872a8044655
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