FDA issued guidance documents to help increase transparency and assist reporting and timely completion of studies on certain medical devices’ safety and effectiveness, explained in a statement by William Maisel, MD, chief medical officer and director of the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological Health:
Today, the FDA issued two draft guidance documents regarding the continuous surveillance of certain FDA approved and cleared devices. When final, these guidance documents will help increase transparency and assist reporting and timely completion of studies on the safety and effectiveness of certain devices.
Even after a device receives FDA clearance or approval to be marketed, our regulatory role continues. We receive and review additional data on certain devices to inform our oversight for the safe and effective use of a device throughout the device lifecycle. These draft guidance documents describing postmarket surveillance of moderate and high-risk devices and post-approval study procedures provide clarity that will help manufacturers better understand the FDA’s requirements and expectations for ongoing data collection for certain approved or cleared devices, which we believe will help increase reporting compliance.
The FDA will continue to reinforce to device sponsors the importance of engaging early and often with the agency to ensure data are properly collected and that all required postmarket studies are properly implemented. Our commitment is to protect the public health by ensuring that devices on the market continue to be safe and effective. FDA’s review of data from post-approval studies and postmarket surveillance is an important part of that commitment.
For more information, visit FDA.
