The FDA seeks to regulate 3D-printed medical devices by Maya M. Eckstein, Paul Nyffeler InsideCounsel | May 17, 2016 • If the AM process results in voids, incomplete bonding or other microstructural issues, testing may be required to establish no ill effects on the final device. Essentially, the applicant must “use all reasonably obtainable knowledge about [their] specific machine’s capabilities to ensure the manufacturing process outputs meet defined requirements.” Post-processing steps of 3D printing, such as cleaning excess starting material or sterilization, could present special challenges for manufacturers. Complex shapes and tortuous pathways, which 3D printing excels at creating, will pose significant issues. The Guidance recommends that applicants “identify any potentially detrimental effects of post-processing and describe mitigations implemented.” This means that rigorous testing will be required to ensure that devices are free from residual manufacturing materials and properly sterilized.

Although end users may not need particular skill to print devices on 3D printers, specialized training may be needed for the proper cleaning and sterilization of printed devices. The Guidance implies that manufacturers who cannot establish that end users will be able to carry out the post-processing steps adequately will not receive approval unless the manufacturers undertake postprocessing themselves. Conclusion The draft Guidance represents the FDA’s first step toward integrating 3D-printed medical devices into its regulatory approval processes. Although the FDA’s thoughts may change during the comment process, applicants hoping to use AM methods now have greater insight into the FDA’s expectations for future device applications. 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 and 3D printing practice groups, 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. Paul Nyffeler is an associate at Hunton & Williams. He advises clients on how to protect intellectual property rights, with particular emphasis on biotechnology, chemicals, and life sciences. He leverages his scientific training and experience in the biotechnology, pharmaceutical, and chemical fields to assist companies and organizations deal with issues such as litigation, patent prosecution, and licensing. He may be reached at (804) 787-8182 or pnyffeler@hunton.com. © 2016 Hunton & Williams LLP 3 .