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Sonali Gunawardhana Discusses Regulatory Implications of 3D-Printed Medical Devices

ABA News
August 11, 2014

Sonali P. Gunawardhana, an attorney in Wiley Rein’s Food & Drug Law Practice, participated in an August 8 panel discussion on the legal and regulatory implications of using 3D printing in the production of medical devices.  The panel was part of the American Bar Association’s (ABA) annual conference and was covered by ABA News.

The Food and Drug Administration (FDA) evaluates all medical devices, including any that use 3D printing technology, for safety and effectiveness, according to the article.  “Although a number of 3D-printed medical devices have received 510(k) clearance through the existing regulatory pathway, the FDA believes novel technologies in development will require new regulatory considerations,” Ms. Gunawardhana, who previously served as regulatory counsel at the FDA, said during the panel.

She said lawyers in related regulatory fields should “learn about how the FDA intends to navigate the challenges of innovative technology, including addressing safety issues as they pertain to mechanical properties, biocompatibility, and the interactive design of 3D medical devices.”

Click here to read the full article.