Web site shows device-safety reports

The FDA, responding to criticism about its oversight of product safety, has put up a Web page that displays safety reports on medical devices after they're on the market. The page includes information from all studies ordered by the FDA since Jan. 1, 2005, on approved devices. No information on clinical data is available because some studies still in process may include trade secrets or display personal information.

Lawmakers and consumer groups have criticized the FDA's monitoring of drugs and devices once they reach the market. The agency says it's creating a network of electronic databases and other surveillance systems to detect safety problems with drugs and devices after they're in wider use.

Usually, companies must submit post-approval status reports every six months for the first two years of the study and annually from that point on until the final report is submitted. Each listing on the new Web page includes the product's name, the approval number and date, and describes the study and whether it's meeting reporting deadlines.

Visit the site at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm

Inspection and compliance help from the FDA

Did you know the FDA posts several inspection and compliance references? The Office of Regulatory Affairs publishes the documents for FDA investigators to use as guidelines for inspections. Find compliance guides at www.fda.gov/ora/compliance_ref/ and inspection reports at www.fda.gov/ora/inspect_ref/.