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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.

  1. Establish comprehensive documentation of AM process workflow from design to final device
  2. Implement process validation protocols considering build orientation and location effects
  3. Develop quality control procedures for material controls and post-processing
  4. Validate cleaning and sterilization processes for complex geometries
  5. Create specific protocols for patient-matched devices including design controls
  6. Establish software validation procedures for entire digital workflow
  7. Implement material characterization and testing protocols
  8. Develop acceptance criteria and testing methods for AM devices
  9. Create labeling procedures specific to AM devices
  10. 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

  • 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
This post is licensed under CC BY 4.0 by the author.