How will the FDA regulate 3D printing? by Maya M. Eckstein and Kyle Sampson InsideCounsel | March 9, 2016 Questions like these abound. Unfortunately, guidance from FDA on 3D printing-related issues seems unlikely. In October 2014, the FDA held a public workshop and requested comments on the “challenges of additively manufacturing medical devices,” suggesting it was preparing guidances for industry on the subject. The The FDA further stated in its 2015 Guidance Agenda that it intended to publish a draft guidance on 3D printing as “resources permit.” Yet, no such guidance appeared in 2015.

FDA’s recently published 2016 Guidance Agenda drops 3D printing completely, suggesting that the agency now has no plans to address the subject publicly. Instead, FDA likely will continue to develop its regulatory approach in the context of particular NDA and 510(k) submissions. Conclusion The FDA’s approvals and clearances of 3D-printed drugs and devices are strong evidence that the agency can review 3D-printed products under its existing regulatory paradigm. Unique questions raised by the new technology, however, suggest that there will be much back-and-forth between manufacturers and the agency.

Although specific guidance from FDA would be useful, it appears that this back-and-forth will occur in the context of particular submissions. Given FDA’s approach, manufacturers of 3D-printed drugs and devices are well-advised to plan ahead and engage the agency early in the development of their products. Maya Eckstein is a partner at Hunton & Williams LLP. She focuses on patent and intellectual property litigation.

As head of the firm’s intellectual property practice group, Eckstein advises companies and organizations on how to protect their valuable intellectual property rights. She represents plaintiffs and defendants in patent infringement disputes and has significant experience planning, coordinating and executing the defense of complex litigation involving multiple defendants and jurisdictions. She may be reached at (804) 788-8788 or meckstein@hunton.com. Kyle Sampson is a partner at Hunton & Williams and a member of the firm’s food and drug practice.

His practice focuses on FDA regulatory, compliance and enforcement issues. Sampson represents food, drug, biologics, medical device, cosmetics and dietary supplement companies on the full range of regulatory and enforcement issues confronting FDA-regulated firms. His practice also includes strategic advice and compliance counseling, enforcement, litigation and transactional matters.

He may be reached at (202) 955-1587 or ksampson@hunton.com. © 2016 Hunton & Williams LLP 3 .