Here are six key points:
1. The FDA released draft guidance on 3D printed medical devices in May, outlining design, manufacturing and testing aspects.
2. The Advanced Medical Technology Association asked the FDA for clarification on “regulatory expectations for point-of-care 3D printing and enhancements to cross center collaborations at FDA,” according to RAPS.
3. AdvaMed asked that the FDA to pinpoint which recommendations apply to patient-specific versus patient-matched devices; the group also wants the FDA to draft a stand-alone guidance for theses products.
4. Device companies are also curious about “data-handling aspects of patient-specific information, privacy, use of patient data for optimization purposes and informed consent that are not unique to additive manufacturing,” according to RAPS.
5. Novartis also requested the FDA’s draft guidance include information on medical devices used in human factor studies and devices used for proof-of-concept and rapid prototyping in clinical studies.
6. As of December 2015, the FDA has approved 85 3D printed devices.
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