The FDA today released a pair of draft guidances on postmarket requirements for certain medical devices.
The first guidance was written to help manufacturers of certain Class II (moderate-risk) and Class III (high-risk) devices for which the agency has issued a postmarket surveillance (522) order. The FDA may issue a 522 order at any time in the lifecycle of such devices that meet any of the following criteria:
- A failure with the device would be reasonably likely to have a serious adverse health consequence.
- The device is expected to be used significantly in pediatric populations.
- The device is intended to be implanted in the human body for more than one year.
- The device is intended to be life-sustaining or life-supporting and used outside of a healthcare facility.
The agency said this first guidance may help manufacturers timely complete their postmarket surveillance plan according to the 522 order and follow FDA policy of posting information about postmarket surveillance in the 522 Postmarket Surveillance Program Database. You can download the draft guidance here.
The second guidance is an updated document written to help companies understand post-approval study requirements imposed as a condition of PMA approval, the agency said. It provides procedural information, recommendations concerning post-approval-related submissions.
The FDA may require a post-approval study as a condition of premarket approval. These studies are typically intended to gather specific data to address questions about the postmarket performance of or experience with an approved medical device. As described in Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval Guidance issued in 2015, the FDA may also consider applying such postmarket controls as a way to reduce premarket data collection, when appropriate, to improve patient access to safe and effective medical devices that are important for public health. The second draft guidance is available here.
“Today, the FDA issued two draft guidance documents regarding the continuous surveillance of certain FDA approved and cleared devices,” said Dr. William Maisel, chief medical officer and director of the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological Health, in a news release. “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,” Maisel added. “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.”