Medical Devices

FDA/CDRH - RSNA SIG Joint Meeting on 3D Printed Patient-specific Anatomic Models, August 31, 2017

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) and Radiological Society of North America 3D printing Special Interest Group (RSNA SIG) have expressed a willingness to leverage their combined strengths for the joint development of the substantive actions of this meeting on the clinical use of 3D printed patient-specific anatomic models (Models). For the past several years, more and more clinical centers have begun to use 3D printed models of patient anatomy. These Models are sometimes produced by the hospital, a medical device manufacturer, or a separate service provider. In each case, the intended use of the Model can greatly influence its appropriateness, difficulty, necessary clinical accuracy, regulatory status and even potential effectiveness. Components of clinical practice and medical device regulation are present throughout the spectrum of uses, necessitating a joint meeting of clinical, industry, and regulatory participants.

This meeting focused on clinically used Models to identify current best practices, levels of benefit v. risk for different intended uses, and gaps in clinical evidence needed to perform effective regulatory review of Models.

Goals and Objectives

The goals and objectives of this workshop were:

  • To provide a forum for open discussion between experts in Models from the clinical, industry, hospital and regulatory fields.
  • To map out priorities for developing scientific evidence, identifying critical quality attributes, and building best practices for the safe clinical use of Models.

Expected Deliverables

  • White paper drafted with the results of discussion on
    • Benefits and risks of anatomic models based on use
    • Technical considerations that inject uncertainty and variability
    • Best practices for safe and effective production of anatomic models
  • Knowledge sharing through goals 1 and 2
  • List of next steps from different stakeholders that would facilitate innovation and development in this space

Who Should Attend

This meeting was intended for a diverse group of experts responsible for the clinical use of Models and regulatory representatives responsible for evaluation of their safety and effectiveness.

The primary audience included leading clinicians, academic experts, medical device companies, regulatory agencies, and representatives of healthcare institutions who are involved with the creation and use of patient-specific anatomic models for clinical applications.
 


Date, Time and Location

This meeting will be held August 31, 2017, beginning at 8:00 a.m. - 5:00 p.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

Webcast

Agenda

StartEndTopicPresenter
8:008:30Welcome, Approval of Past Minutes & Ground RulesRSNA SIG & FDA
8:308:40Examples that Frame DiscussionsRSNA SIG / Andy C
8:409:00Technical Guidance OverviewFDA/OSEL
9:009:30

Industry Practice Insights

Stratasys
3D Systems
Materialise
9:309:50FDA Current Practices and RegulationsOIR
9:5010:15SIG - RSNA Board and Recommendations DocumentRSNA SIG / Frank R
10:1510:30Break 
10:3012:10Clinical Appropriateness for 3D PrintingRSNA SIG / Adnan S
12:1013:10Working Lunch, SIG Business Meeting, Q&A 
13:1013:20Intro to BreakoutsRSNA SIG & FDA
13:1016:10

Three Breakouts

  • Benefit vs Risk: What are the benefits (quantitative and perceived) and the potential risks of 3D printed anatomic models for different intended uses?
  • Technical Considerations for Safety: What are the engineering, design and human factors challenges in making 3D printed anatomy? (e.g. repeatability, training) How do we meet them?
  • Practice Insights: What types of clinically relevant features that need be replicated to make clinically useful and accurate models? (e.g. 1mm blood vessels, 4mm defect) Can they be standardized? How similar are they between intended uses? How can we determine the limits and increase the available data?
 
16:1016:40Group Reports: 3x10Group Leads
16:4017:00Wrap-upRSNA SIG & FDA

Registration to Attend the Workshop

Online registration is closed as of August 30, 2017.

There is no fee to register for the Meeting and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

Contact Us

If you require special accommodations due to a disability, or need additional information regarding registration,please contact Susan Monahan, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661, susan.monahan@fda.hhs.gov.

For questions regarding workshop content please contact:

LCDR James Coburn
FDA/CDRH/OSEL
Building 62, Office 1117
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 21029

Page Last Updated: 09/20/2017
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