Outside Publication

FDA Issues Final Rule on Data Acceptance from Clinical Investigations for Medical Devices, Applied Clinical Trials

March 07, 2018

Morgan Lewis & Bockius LLP partners Kathleen Sanzo and Phoebe Mounts, and associate Suzanne Bassett authored an article for Applied Clinical Trials about the US Food and Drug Administration’s final rule on standards for accepting data from clinical investigations for medical devices. Under the new rule, enacted February 21, 2018 and effective a year later, the FDA is requiring sponsors and applicants to affirm that clinical investigations outside the United States were conducted in accordance with Good Clinical Practices (GCPs) when the data are submitted for medical device applications.

Read the full Applied Clinical Trials article >>