FDA Provides Web Access to Postapproval Study Data

The FDA announced the availability of a new web page to post the status of postapproval studies for medical devices.

The new web page includes information on all postapproval device studies ordered by the agency since Jan. 1, 2005. Listings include the company's name, the product's name, the approval number and date and a description of the study and whether it is meeting its reported deadlines.

No information on clinical data will be available because the studies may be ongoing and include personal and confidential information, the agency said.

In December 2006, the FDA announced plans for the new web page in a guidance document on reporting postapproval studies. There are currently more than 40 listings on the web page, according to the FDA.