FDA published guidance on additive manufacturing technical considerations in late 2017, outlining the Agency’s long-awaited position on use of the technology for medical devices. At the time, FDA said that the 31-page document was considered “leapfrog” guidance, a term reserved for the Agency’s anticipation that its initial thoughts on an emerging technology will change over time. In short, more questions and answers have arisen — and will continue to do so as the technology is adopted. This FDA guidance is critical to the additive manufacturing narrative. However, standards and best practices surrounding the technology are being discussed globally on a daily basis. This discussion puts representatives from ASTM, FDA, SME and DePuy Synthes in one room, for one conversation, that will provide attendees with practical, actual guidance not only for current times, but also for what is on the horizon.

2. PANEL DISCUSSION
Developing a Roadmap for Regulatory
Guidance and Standards
Moderated by
Lauralyn McDaniel
SME

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Carl Dekker
President
Met-L-Flo
• ASTMF42
• SME Medical AM3DP Workgroup

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Dan Fritzinger
Manager, Global Instrument Innovation
DePuy Synthes
• AMSC Medical Co-chair
• SME Medical AM3DP Workgroup

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David Hwang
Biomedical Engineer
CDRH, Office of Device Evaluation
Division of Orthopedics
US Food & Drug Administration

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Let’s get to know a little about you…
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• Standards
• 2009: ASTM F42
• 2016: Launch of AMSC
• Regulations—FDA
• 2014: Public Workshop
• 2016: Draft Guidance
• 2017: Technical Guidance
A little history…
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Additive Manufacturing Standardization
Collaborative (AMSC)
• America Makes and ANSI
• Coordinate and accelerate the
development of standards
• Roadmap Version1.0—February 28, 2017
• Several SDOs are involved (ASTM, ASME, SAE,
AWS, MITA, AAMI, etc.)
• More than 200 volunteers
• www.ansi.org/amsc

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AMSC Roadmap
• Identified 89 gaps across all applications and industries
• Priority
• Related standards
• In development work
• Potential SDOs
• Gap summary table

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 D4: Application-Specific Design Guidelines
 D14: Designing to be Cleaned
 D18: New Dimensioning and Tolerancing
Requirements
 PM5: Feedstock Sampling
 PC2: Machine Calibration and Preventive
Maintenance
 PC7: Recycle & Re-use of Materials
 PC9: Environmental Conditions: Effects on Materials
 PC14: Environmental Health and Safety: Protection
of Machine Operators
High Priority Gaps – Version 1.0

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 FMP3: Cleanliness of Medical AM Parts
 QC1: Harmonization of AM Q&C Terminology
 QC2: Qualification Standards by Part Categories
 QC9: Personnel Training for Image Data Set Processing
 QC10: Verification of 3D Model
 NDE1: Terminology for the Identification of AM Flaws
Detectable by NDE Methods
 NDE3: Standard Guide for the Application of NDE to
Objects Produced by AM Processes
High Priority Gaps – Version 1.0

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Additional Gaps Specific to Medical
 Gap D12: Imaging Consistency
 Gap D13: Image Processing and 2D to 3D Conversion
 Gap QC6: Importing Ultrasound Data
 Gap QC7: Protocols for Image Accuracy
 Gap QC8: Phantoms
 Gap QC14: Segmentation
 Gap QC15: Sterilization of Anatomical Models

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Published Standards—
Some of the published most relevant to orthopedic implants
 ISO / ASTM52921: Terminology for Additive Manufacturing
 ISO / ASTM52910 – 17: Design for AM
 ASTM F3001: Powder bed fusion of Ti-6Al-4V ELI
 ASTM F3049: Characterizing properties of metal powders
 F3122-14: Evaluating mechanical properties
or metal materials
 ASTM F3184-16: Powder bed fusion of UNS S31603
 ASTM F3213: Powder bed fusion of Co-Cr-Mo
 DICOM Supplement 205-Encapsulation of STL

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In Development
 DICOM Update—Encapsulation of additional formats
 ASTM WK60265: Removal of Additive Manufacturing Residues in
Medical Devices Fabricated by Powder-bed Fusion
 ISO/ASTM NP 52916: Optimized medical image data

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More to come…
 AMSC Development Roadmap 2.0: June 2018

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Finding Standards & Work Items
www.sme.org/am3dp

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Questions
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