The FDA’s Center for Devices and Radiological Health (CDRH) and Radiological Society of North America 3D printing Special Interest Group (RSNA SIG) will be holding a workshop on Aug. 31 regarding the clinical use of 3D printed patient-specific anatomic 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. According to the groups, 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.
The meeting will focus on clinically used models to identify current best practices, levels of benefit versus risk for different intended uses, and gaps in clinical evidence needed to perform effective regulatory review of models. Based on the feedback from the discussion, the groups aim to publish a white paper covering the benefits and risks of anatomic models based on us; technical considerations that inject uncertainty and variability; and best practices for safe and effective production of anatomic models.
Expected to attend are 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.
The Aug. 31 meeting will be held from 8 a.m. to 5 p.m. at the FDA White Oak campus in Silver Spring, Md.
Interested participants must register by 4 pm on Aug. 29.
