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Quality Digest

FDA Compliance

FDA Provides Web Access

Published: Tuesday, April 24, 2007 - 22:00

(Food and Drug Administration: Rockville, Maryland) The U.S. Food and Drug Administration has unveiled a new Web page that will keep the public informed about the status of post-approval patient studies for certain recently approved medical devices. “FDA is committed to improving its medical device safety program and ensuring that medical devices remain safe and effective once they are in the hands of health professionals and the public,” says Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “Electronic access will give the public an opportunity to see progress being made on a company’s post-market commitments.”

Modern devices provide significant health benefits, but experience has shown that the full magnitude of some potential risks doesn’t always emerge during the mandatory clinical trials that are required for approval. FDA sometimes orders post-approval studies to address remaining issues such as the product’s performance once it becomes more widely available or is used over a longer period of time.

Generally, companies must submit interim post-approval study status reports every six months for the first two years of the study and annually thereafter until the final report has been submitted.

FDA’s new Web page includes information on all post-approval device studies ordered by FDA since Jan. 1, 2005. Each listing includes the company’s name, the product’s name, the approval number and date, and describes the study and whether it is meeting its reporting deadlines. No information on clinical data is available because the studies may be ongoing and include personal and confidential information. There are currently more than 40 listings on the Web page.

The Institute of Medicine called for public reporting of post-market studies in a 2005 study on pediatric devices. That same year, FDA initiated an internal review of its ability to monitor post-approval studies. As a result, the agency shifted responsibility for tracking these studies from its pre-market staff to its post-market staff and set up a new electronic system for them to do so.

In December 2006, FDA disclosed plans for the new Web page in a guidance document on how to report post-approval studies. In January 2007, FDA began discussing the status of ongoing studies at its advisory committee meetings.

Improved communication about post-approval studies is just one of FDA’s many efforts to strengthen post-market device safety. FDA is currently implementing an ambitious action plan drawn up last year by a Post-Market Device Transformation Leadership Team, a group of experts drawn from both inside and outside of FDA. Its action items include pursuing the development of a unique identifier system to identify a device and the information associated with that 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.

For more information, visit www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm.

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