FDA Launches New Studies Web Page
American Academy of Sleep Medicine
Thursday, April 12, 2007
Recognizing potential risks don't always manifest during mandatory clinical trials required for the approval of medical devices, the Food and Drug Administration (FDA) has launched a Web site, www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm, which provides updates on post-approval studies.
The site currently lists 44 records on FDA-ordered post-approval device studies.