Draft Guidance of 3D Printing Medical Devices issued by FDA on May 10, 2016
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Transcript of Draft Guidance of 3D Printing Medical Devices issued by FDA on May 10, 2016
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Draft Guidance of 3D Printing Medical DevicesIssued by FDA on May 10, 2016
Christina Huang2016/05/18
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Overview
To outline technical aspects of an AM device that should be considered through the phases of development, production process, process validation, and final device testing.
Scope: Design and manufacturing considerations Device testing considerations
BiologicalCellularTissue-based products
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AM Classifications
Powder fusion Stereolithography Fused filament fabrication Liquid-based extrusion
Advantages: (1) using patient’s own medical imaging(2) ease in fabricating complex structures
Concerns:(1) relative lack of medical history experiences(2) challenges in characterization and assessment
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Design and Manufacturing Process Considerations Standard-sized device
Compare the desired feature size to final device Document dimensional specifications and tolerances Check pixelation caused by mismatch
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Design and Manufacturing Process Considerations Patient-matched device
Refer to “customized” devices not custom devices, which meet FD&C requirement: ≦5 pcs/yr of a type
Often made by altering features of the standardized Clearly identify design parameters and its range, and which of
these can be modified for patient-matching
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Design and Manufacturing Process Considerations Patient-matched device
Effects of imaging (recommend): 1) note the range of deformation experience by the target location/tissue vs. reference image2) consider the potential time to produce since patient anatomy changes over time
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Design and Manufacturing Process Considerations Patient-matched device
Interacting with design models (recommend): 1) design software identify the iteration of changes2) all medical devices and accessories is validated
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Design and Manufacturing Process Considerations Software workflow
File format conversions:1) test all file conversion with simulated worse-case2) software changes may trigger revalidation3) final files for printing should be maintainedas AMF format in ISO/ASTM 52915 “Standard specification for additive manufacturing file format”
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Design and Manufacturing Process Considerations Software workflow
Digital device design to physical device:1) build volume placement: distance between each component, orientation of each component, difference between machines affect final properties
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Design and Manufacturing Process Considerations Software workflow
Digital device design to physical device:2) addition of (temporary) support material: location, type, number affect geometric accuracy and mechanical properties analyze geometry and other requirements
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Design and Manufacturing Process Considerations
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Design and Manufacturing Process Considerations Software workflow
Digital device design to physical device:3) slicing: layer thickness choice (depends on surface texture, bonding ability, powder sensibility)4) build paths: document building path space between each building path, path speed impact the quality of final device
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Design and Manufacturing Process Considerations Software workflow
Digital device design to physical device:5) machine parameters and environmental conditions:
power of energy system and energy densitybuild/beam speed and pathfocal point or nozzle diameter, etc
use qualified machine with qualified installation
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Design and Manufacturing Process Considerations Material control
Starting material: document material and chemical names, trade names, Chemical Abstracts Service (CAS) number, material supplier, and incoming material specifications
Material recycling (if applicable): describe the recycling process, and document evidence for coherent final device properties
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Design and Manufacturing Process Considerations Nothing listed here depends on build methods
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Design and Manufacturing Process Considerations Post-processing:
From cleaning to annealing for desired properties and Ra document all steps and include a discussion of the effects on the materials and device hard-to-reach spaces: effects assessment
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Design and Manufacturing Process Considerations Process validation and acceptance activities:
Process validation: parameters, process steps, software document monitoring and control methods and dataEstablish criteria for determining successful final device
Revalidation: when changes in manufacturing process Acceptance activities: ASTM Committee F42 on AM tech. Test coupons: the worse-case for destructive tests
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Design and Manufacturing Process Considerations Quality data:
Ensure the quality data (such as build volume location) can be analyzed enable proper identification of quality problems and investigation of the cause of nonconformities
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Design and Manufacturing Process Considerations Device description Mechanical testing Dimensional measurements Material characterization Cleaning and sterilization Biocompatibility and Labeling
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Device Testing Considerations
Device description: Dimensions, design variations, allowance, critical features, type of AM technology used (inc. a process flow chart)
Mechanical testing: Generally the same as that for a device manufactured by a traditional method+ consideration of build orientation and location
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Device Testing Considerations
Dimensional measurements:Device dimensions may be affected by orientation and location of the build volume specify and measure
Material characterization: Material chemistry: e.g. chemical component Material physical properties: interlayer bonding, properties for
metal/ceramics, polymer, the absorbable
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Device Testing Considerations
Cleaning and sterilization:Challenges posed by the complex geometries (consider in worse-case for destructive testing on final device)
Biocompatibility and Additional labeling ISO 10993 “Biological Evaluation of Medical Devices
Part 1: Evaluation and Testing” Labels of identification, and precaution is recommended
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Comments?
FDA is open for comments and suggestions till August 8, 2016http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/3DPrintingofMedicalDevices/default.htm
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THANKS