On February 21, 2018, FDA amended its regulations on the acceptance of data from clinical investigations for medical devices. Under the new rule, FDA requires that data submitted from clinical investigations conducted outside of the U.S. (OUS) intended to support an IDE or application or submission for a device be from investigations conducted in accordance with good clinical practice (GCP). This guidance document is intended to help sponsors and applicants understand and comply with these new requirements (FDA.gov)