FDA Makes Post-Approval Device Study Info Public
BY LAUREN UZDIENSKI, APRIL 10, 2007
Plans for more rigorous post-marketing policy are underway at the FDA with a new website that tracks post-approval device studies. The website names the manufacturer, device, study description and study status. There is no specific info on clinical studies because they could be ongoing and include personal and confidential data.
The website, updated monthly, addresses safety and performance concerns for newly-approved devices. Among the products currently being monitored are devices from Biomet, Depuy and Zimmer, as well as Kyphon's X-Stop, Smith & Nephew's Birmingham Hip and Synthes' ProDisc.
In their press release, the FDA explained that clinical trials required for a PMA submission may not show risks that appear in a larger population or over a longer period of time. Following up on new devices can increase physician and public confidence in a device that may have been approved with little or limited clinical data. For this reason, many companies conduct their own post-marketing studies that are not required by the FDA.
The website has been in the works since 2005, when the FDA initiated a review of post-marketing procedures. It's the first of a series of recommendations from the FDA's Post-market Device Transformation Leadership Team. Others include developing a unique identifier system to identify a device and information associated with it throughout its lifetime, mandatory use of electronic reporting for required adverse event reports and revising the CDRH's current system of adverse event reporting.
