Tag Archives: Regulation

3D printing could expand medical device regulation: Here’s how

FDA today offered a clearer picture of how it plans to regulate the 3D printing of medical devices – including in non-traditional settings such as medical facilities and academic institutions.

FDA 3D printing“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 3D-printed personalized devices for specific patients they are treating,” FDA Commissioner Scott Gottlieb said in a statement.

Gottlieb also highlighted new guidance that clarifies what the FDA in the U.S. would like to see in submissions for 3D-printed medical devices. The guidance includes FDA regulators’ thinking on device design, testing of products for function and durability, and quality system requirements when it comes to 3D printing. FDA is describing the document as a “leapfrog guidance” because it offers initial thoughts on technologies emerging in the industry.

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Regulating a 3D printing revolution

3D printing3D printing is revolutionizing manufacturing practices with wide-ranging uses from medical devices to automobile parts. But the ready availability of 3D printers, combined with the ease with which computer-aided designs (CADs) can be shared, makes 3D printing particularly vulnerable to easy reproduction and distribution without prior permission of designers.

In a recent article, Professor Peter Menell of the University of California, Berkeley and Professor Ryan Vacca of the University of Akron School of Law argue that regulating 3D technology successfully will depend on a combination of the industry’s strategic approach to enforcement and the willingness of courts to amend existing copyright laws to fit the particularities of 3D printing.

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The evolving regulatory landscape of 3D printed medical products

Over the past year, my email inbox has been consistently pinged by law firms advertising seminars and workshops that promise to help medical professionals understand what is noteworthy for 3D printed medical products, ranging from regulatory to IP concerns.  Some of these have been quite alarming, seeming to indicate that as disruptive as 3D printing promises to be, there must be a corresponding disruption to how we work on regulatory compliance to protect our assets.

But if we step back and look at the actual Food and Drug Administration (FDA) communications, the pace of adoption of 3D printing and real intersections of 3D printing and business processes, it appears that little has changed. The only disruption is when 3D printing revolutionizes a commercial process.

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European Parliament calls for common and competitive 3D printing strategy

The European Parliament, the second largest democratic electorate and largest trans-national democratic electorate in the world, met this week for the second Additive Manufacturing and 3D Printing European Conference, where it highlighted the pressing need for a common European strategy to advance 3D printing research, materials, education, market value and overall technological development.

At the 2015 Additive Manufacturing and 3D Printing European Conference, the need for a common, trans-national strategy became obvious. Now, at the 2016 Conference, high-level representatives from companies, institutions, and the machine tools sector gathered once again to put a plan into action.

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