FDA Issues Draft Guidance for 3D Printed Medical Devices

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The U.S. Food and Drug Administration (FDA) issued draft guidance for additive manufactured medical devices, more commonly known as 3D printed medical devices, on May 10, 2016. The draft guidance document, available here, is for comment only and includes technical considerations for such devices.

The draft guidance states that the FDA developed the guidance “to provide FDA’s initial thinking on technical considerations specific to devices using additive manufacturing” and to outline “recommendations for testing and characterization for devices that include at least one [Additive Manufacturing] fabrication step.” The document addresses two broad areas: 1) design and manufacturing considerations, and 2) device testing considerations including characterization, validation and verification.

However, the guidance is not comprehensive.  According to the Regulatory Affairs Professionals Society (RAPS), the “FDA says the guidance is not intended to address 3D printed products containing biologics, cells or human tissues, and cautions that ‘point-of-care device manufacturing may raise additional technical considerations’ not covered in the draft guidance.” RAPS further indicates that the guidance resulted from a public workshop in 2014 and that “the major takeaways from the workshop include the importance of material control, the impact of the 3D printer and post-printing processes on final device performance and the need for a ‘robust process validation and acceptance protocol.’”

According to the FDA, the public has until early August to provide comments on the draft guidance.

Tom Cowan
Tom is a Partner in the San Diego office and serves clients worldwide in aerospace, mechanical, and medical technologies. He counsels clients on overall IP strategy, performs IP audits, prosecutes patents and trademarks, conducts pre-litigation enforcement of IP rights, negotiates licenses, and conducts offensive and defensive diligence such as patentability and infringement studies. As a former aerospace engineer with experience at NASA and Northrop Grumman, and holding a master’s degree in biomedical engineering, Tom’s legal services are supplemented with his advanced technical abilities in a wide range of inventive domains. Tom has particular experience with assisting startups from the conceptual design phase through acquisition. One recent example is Millipede, Inc., developer of a heart valve annuloplasty device. Tom prosecuted their patent portfolio and provided defensive patent diligence, resulting in investments and an acquisition by Boston Scientific totaling $540,000,000. Other example particular technologies in Tom’s patent experience include cardiac devices, intracranial sensors, prosthetics, aircraft and rockets, robotics, unmanned aerial vehicles (drones), semiconductors, imaging and biosensors, high altitude balloons, control systems, thermal management systems, software, and more. Additional highlights include: Keynote Speaker, “Patent Basics for the Aerospace Industry,” at the 2019 Space Foundation Space Commerce Workshop Former Mechanical engineer at Northrop Grumman, where he designed and tested complex structures and mechanisms for various spacecraft programs Interned at NASA Armstrong Space Center, Aerodynamics Branch, where he analyzed data for the Quiet Supersonic Platform Inventor of the “Inflate-A-Brake,” a system for de-orbiting small satellites to reduce space debris Publications Coordinator for the firm’s medical device practice group, which leads the nation in medical device patent prosecution having obtained over 4,800 medical device patents since 1976 and 2,700 medical device patents since 2010 Member of the firm’s pro bono committee and coordinates with the U.S. Patent & Trademark Office’s regional patent pro bono program to assist indigent individuals and non-profit organizations Co-Chair of the Licensing Executives Society (LES) for the San Diego Chapter Holds a minor in Chinese and studied Chinese language and history at Shaanxi Normal University in Xian, China
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