New Site Monitors Post-Approval Device Studies

FDA today unveiled a new yeezy pas cher Web site that tracks post-approval studies for approved medical devices. The site, which currently has about 40 listings, includes information on all post-approval device studies ordered by FDA since January 1, 2005. Each listing includes the company’s name, the product’s name, and the approval number and date, and describes the study and whether it is meeting its reporting deadlines. Information on clinical data is excluded, as the studies may be ongoing. In the wake of harsh criticism over the agency’s lack of post-approval monitoring of drug-eluting stents, FDA unsurprisingly assures in its press release that the yeezy pas cher new Web site is “just one of FDA’s many efforts to strengthen post-market device safety.” Specifically, according to the statement, FDA is currently implementing an action plan that was created last year by a Post-Market Device Transformation Leadership Team. That group, which is made up of experts from both inside and outside FDA, drew up action items that include the following: development of a system that would identify a device throughout its lifetime, mandatory use of electronic reporting for required adverse event reports, and revising the Center for Devices and Radiological Health’s current system of adverse event reporting.

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