- August 31, 2017
4:00 AM - 1:00 PM ET
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.
- 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.
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
|8:00||8:30||Welcome, Approval of Past Minutes & Ground Rules||RSNA SIG & FDA|
|8:30||8:40||Examples that Frame Discussions||RSNA SIG / Andy C|
|8:40||9:00||Technical Guidance Overview||FDA/OSEL|
Industry Practice Insights
|9:30||9:50||FDA Current Practices and Regulations||OIR|
|9:50||10:15||SIG - RSNA Board and Recommendations Document||RSNA SIG / Frank R|
|10:30||12:10||Clinical Appropriateness for 3D Printing||RSNA SIG / Adnan S|
|12:10||13:10||Working Lunch, SIG Business Meeting, Q&A|
|13:10||13:20||Intro to Breakouts||RSNA SIG & FDA|
|16:10||16:40||Group Reports: 3x10||Group Leads|
|16:40||17:00||Wrap-up||RSNA SIG & FDA|
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.
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, firstname.lastname@example.org.
For questions regarding workshop content please contact:
LCDR James Coburn
Building 62, Office 1117
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 21029