News | Medical 3-D Printing | January 03, 2018

FDA Announces Final Guidance and Webinar for Technical Considerations for 3-D-Printed Medical Devices

Guidance provides manufacturers with recommendations for device design, manufacturing and testing

FDA Announces Final Guidance and Webinar for Technical Considerations for 3-D-Printed Medical Devices

January 3, 2018 — The U.S. Food and Drug Administration (FDA) issued the final version of the guidance, “Technical Considerations for Additive Manufactured Medical Devices." Additive manufacturing (AM), the broad category of manufacturing encompassing three-dimensional (3-D) printing, is an emerging technology. This guidance is not intended to introduce new policy, but rather outlines the Agency’s current thinking about the technical aspects associated with AM processes, and provides manufacturers with recommendations for device design, manufacturing and testing considerations for use when developing devices that include at least one additively manufactured component or additively fabricated step.

In medical device applications, AM has the advantage of facilitating the creation of anatomically-matched devices and surgical instrumentation by using a patient's own medical imaging data. Another advantage is the ease in fabricating complex geometric structures, allowing the creation of engineered open lattice structures, tortuous internal channels and internal support structures that would not be easily possible using traditional (non-additive) manufacturing approaches. However, the unique aspects of the AM process, such as the layer-by-layer fabrication process, combined with the relative lack of experience and clinical history with respect to devices manufactured using AM techniques, pose challenges in determining optimal characterization and assessment methods for the final finished device, as well as optimal process validation and verification methods for these devices. For devices manufactured using AM, the recommendations in this guidance supplement any device-specific recommendations outlined in existing guidance documents or applicable FDA-recognized consensus standards.

On Jan. 10, 2018, the FDA will hold a webinar from 1:00-2:30 p.m. Eastern Time for industry to review the “Technical Considerations for Additive Manufactured Medical Devices” guidance document and answer questions. No registration is required.

FDA Commissioner Scott Gottlieb, M.D., said, “Today we are issuing new guidance to help advise device manufacturers on technical aspects of 3-D printing, referred to as additive manufacturing, that clarifies what the FDA recommends manufacturers include on submissions for 3-D-printed medical devices. It includes our thinking on various approaches to 3-D printing, including device design, testing of products for function and durability, and quality system requirements. Overall, it will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and making sure our regulatory approach is properly tailored to the unique opportunities and challenges posed by this promising new technology.”

Gottlieb continued, “But this technical guidance — categorized as a “leap-frog” guidance because it helps bridge where we are today with innovations of tomorrow — is only intended to provide the FDA’s initial thoughts on an emerging technology with the understanding that our recommendations are likely to evolve as the technology develops in unexpected ways. We are already seeing the beginning of this evolution as hospitals and academic centers use their own 3-D printers to create innovative dental implants, replacement knee joints, and experimental heart valves and bone implants for use in clinical studies. An increasing number of surgeons across the country have been saving infants born with a life-threatening breathing condition by creating patient-matched 3-D-printed splints to install in their patients’ tiny airways, which expand and degrade as the babies grow.

“In order to help ensure the safety and effectiveness of these products, we’re working to establish a regulatory framework for how we plan to apply existing laws and regulations that govern device manufacturing to non-traditional manufacturers like medical facilities and academic institutions that create 3-D-printed personalized devices for specific patients they are treating. Developing a transparent policy on 3-D printing remains an important next step for us, and we plan to explore the role of nontraditional manufacturing facilities like a hospital operating room or university laboratory,” Gottlieb concluded.

The FDA also plans to review the regulatory issues related to the bioprinting of biological, cellular and tissue-based products in order to determine whether additional guidance is needed beyond the recently released regulatory framework on regenerative medicine medical products.The Center for Biologics Evaluation and Research has recently interacted with more than a half-dozen manufacturers who have expressed interest in using 3D printing in some capacity to produce their medical products.

 

Related 3-D Printing Content:

The Future of 3-D Printing in Medicine

VIDEO: Applications in Cardiology for 3-D Printing and Computer Aided Design

The Use of 3-D Printing in Cardiology

 

For more information: www.fda.gov

Related Content

Virtual Reality 3-D Models Help Yield Better Surgical Outcomes

Joseph Shirk, M.D., of UCLA with the virtual reality headset. Image courtesy of UCLA Jonsson Comprehensive Cancer Center

News | Virtual and Augmented Reality | September 25, 2019
A UCLA-led study has found that using three-dimensional virtual reality (VR) models to prepare for kidney tumor...
3D Systems Earns Additional FDA Clearance for D2P Medical 3-D Printing Software

3D Systems’ D2P FDA-cleared software allows clinicians to 3-D-print diagnostic patient-specific anatomic models. Image courtesy of 3D Systems.

Technology | Medical 3-D Printing | September 12, 2019
3D Systems has received additional U.S. Food and Drug Administration (FDA) 510(k) clearance for its D2P software...
A 3-D printed tungsten pre-clinical X-ray system collimator. 3D printed, additive manufacturing for medical imaging.

A 3-D printed tungsten pre-clinical X-ray system collimator. The tungsten alloy powder is printed into the form desired and is laser fused so it can be machined and finished. Previously, making collimators from Tungsten was labor intensive because it required working with sheets of the metal to create the collimator matrix. 

Feature | Medical 3-D Printing | September 04, 2019 | By Steve Jeffery
In ...
Delaware Imaging Network Now Offers NeuroQuant Brain Imaging MRI Software
News | Neuro Imaging | August 29, 2019
Delaware Imaging Network (DIN), Delaware’s largest network of outpatient medical imaging centers, has added NeuroQuant...
Smoldering Spots in the Brain May Signal Severe MS

NIH researchers found that dark rimmed spots representing ongoing, “smoldering” inflammation, may be a hallmark of more disabling forms of multiple sclerosis. Image courtesy of Reich lab, NIH/NINDS.

News | Neuro Imaging | August 22, 2019
Aided by a high-powered brain scanner and a 3-D printer, National Institutes of Health (NIH) researchers peered inside...
RSNA and ACR to Collaborate on Landmark Medical 3D Printing Registry
News | Medical 3-D Printing | August 08, 2019
The Radiological Society of North America (RSNA) and the American College of Radiology (ACR) will launch a new medical...
Synaptive Medical Launches Modus Plan With Automated Tractography Segmentation
Technology | Neuro Imaging | August 07, 2019
Synaptive Medical announced the U.S. launch and availability of Modus Plan featuring BrightMatter AutoSeg. This release...
TeraRecon Unveils iNtuition AI Data Extractor
News | Advanced Visualization | July 03, 2019
Artificial Intelligence (AI) and advanced visualization company TeraRecon announced its new iNtuition AI Data Extractor...
A 3-D printed model (left) and a model constructed in augmented reality (right), both of a kidney with a tumor. In both models, the kidney is clear; the tumor is visible in purple on the AR model and in white on the 3-D printed model.

A 3-D printed model (left) and a model constructed in augmented reality (right), both of a kidney with a tumor. In both models, the kidney is clear; the tumor is visible in purple on the AR model and in white on the 3-D printed model. Photo courtesy of Nicole Wake, Ph.D.

Feature | Advanced Visualization | July 02, 2019 | By Jeff Zagoudis
Three-dimensional (3-D) printing and...

Image courtesy of Philips Healthcare

Feature | Molecular Imaging | July 01, 2019 | By Sharvari Rale
Diagnostic procedures have always been a cornerstone of early prognosis and patient triaging.