Human Subject Protection; Acceptance of Data from Clinical Studies for Medical Devices

The information collection updates the standards for FDA acceptance of data from clinical investigations conducted outside the United States and helps ensure the protection of human subjects and the quality and integrity of data obtained from these investigations. We are also amending the investigational device exemption (IDE) and premarket notification (510(k)) regulations to address the requirements for FDA acceptance of data from clinical investigations conducted inside the United States. The amendments are intended to provide consistency in FDA requirements for acceptance of clinical data, whatever the application or submission type. The information collection includes additional maintenance, retention, and submission of documents indicating (1) clinical investigations conducted outside the United States and used to support IDE or device marketing applications or submissions are conducted in accordance with good clinical practice (GCP), and (2) availability of data for FDA inspection, if deemed necessary. The information allows reviewers to assess the appropriateness and adequacy of the clinical investigation design, data collection plans, conduct, and performance, and helps to protect human subjects participating in medical device clinical investigations.

The latest form for Human Subject Protection; Acceptance of Data from Clinical Studies for Medical Devices expires 2021-05-31 and can be found here.