Technical Considerations for Additive Manufactured Medical Devices
This FDA guidance outlines technical considerations specific to medical devices manufactured using additive manufacturing (AM) or 3D printing technologies. It covers design and manufacturing process considerations as well as device testing considerations for devices that include at least one additively manufactured component or step.
Recommended Actions
- Establish comprehensive documentation of AM process workflow from design to final device
- Implement process validation protocols considering build orientation and location effects
- Develop quality control procedures for material controls and post-processing
- Validate cleaning and sterilization processes for complex geometries
- Create specific protocols for patient-matched devices including design controls
- Establish software validation procedures for entire digital workflow
- Implement material characterization and testing protocols
- Develop acceptance criteria and testing methods for AM devices
- Create labeling procedures specific to AM devices
- Establish revalidation triggers and procedures for process changes
Key Considerations
Non-clinical testing
- Mechanical testing should be conducted on final finished devices after all post-processing
- Consider worst-case combinations of dimensions and features
- Account for build orientation and location effects on properties
- Perform dimensional measurements on samples from multiple build cycles
- Validate process parameters and controls
Software
- Validate software workflow and file format conversions
- Implement internal checks in design manipulation software
- Maintain data integrity throughout file conversions
- Consider cybersecurity for patient-matched devices
- Document build preparation software parameters
Cybersecurity
- Implement proper management of personally identifiable information (PII)
- Protect patient health information (PHI)
- Follow FDA cybersecurity guidance for interactive patient matching workflows
Labeling
- Include patient identifier for patient-matched devices
- Specify intended use
- Indicate final design iteration/version
- Include expiration date based on imaging/design date
- Add precaution about checking for anatomical changes
- Provide reprocessing instructions if applicable
Biocompatibility
- Evaluate biocompatibility of final finished device per ISO 10993-1
- Consider additional testing if using chemical additives with known toxicities
- Assess material chemistry changes during manufacturing
Safety
- Validate cleaning processes to remove manufacturing residues
- Validate sterilization processes considering complex geometries
- Document material reuse protocols and effects
- Implement process controls and monitoring
- Establish acceptance criteria
Other considerations
- Document material specifications and controls
- Validate post-processing steps
- Consider build orientation and location effects
- Implement quality data tracking
- Validate process for patient-matched devices
Relevant Guidances
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Content of Premarket Submissions for Device Software Functions
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
Related references and norms
- ISO/ASTM 52900: Additive manufacturing — General principles — Terminology
- ISO 14971: Medical devices - Applications of risk management to medical devices
- ISO 10993-1: Biological evaluation of medical devices
- ASTM F3122: Standard Guide for Evaluating Mechanical Properties of Metal Materials Made via Additive Manufacturing Processes
- ISO/ASTM 52915: Standard specification for additive manufacturing file format (AMF)
Original guidance
- Technical Considerations for Additive Manufactured Medical Devices
- HTML / PDF
- Issue date: 2017-12-05
- Last changed date: 2020-03-02
- Status: FINAL
- Official FDA topics: Biotechnology, Orthopedic, Medical Devices, Premarket Approval (PMA), Tissue, 510(k), Premarket, Biologics, HUD/HDE, Investigational Device Exemption (IDE)
- ReguVirta summary file ID: 0eb6b0a5309e98b1d2bed015af6c0444
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