Report: FDA Can't Track Post-Market Device Studies

07/18/2005
Dow Jones News Services
(Copyright © 2005 Dow Jones & Company, Inc.)




By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES

WASHINGTON (Dow Jones)--The U.S. Food and Drug Administration can't effectively track post-market studies it sometimes requires medical device manufacturers to undertake after the devices are on the market, a report from the Institute of Medicine said Monday.

The Institute of Medicine, a private, nonprofit institution that provides health policy advice as part of a congressional charter granted to the National Academy of Sciences, was required by Congress to look at FDA monitoring of medical devices used in children.

The report said that device makers who conduct post-market studies are required to report annually to FDA on their studies' progress, but that the FDA doesn't have a system in place to track the progress of the studies like it does for drug studies. The FDA is required to report by 2007 to Congress about the status post-market device studies and is currently setting up a system to track the studies.

The Institute of Medicine said, however, Congress should require FDA to report annually on medical device studies and that the database should be made available to the public. The institute's report said it found little information about studies ordered specifically for medical devices used in children mainly because it found little information for device studies overall.

"Although dozens of these study commitments have been made, FDA could not identify which involved children, nor say which studies had been initiated or completed or otherwise confirm their progress," the report said.

The institute said FDA needed more authority to order post-marketing studies for devices that go through the FDA's so-called clearance process. The FDA can order post-marketing studies for more complicated devices that so through an approval process much like the system in place for the drug-approval process.

According to FDA, about 80,000 medical devices are marketed in the United States, ranging from plastic tubing and baby bottle nipples that don't need approval to others as complex as pacemakers or cerebrospinal fluid shunts. Slightly more than half of all devices are required to go through the FDA's approval process while many others go through a less-rigorous clearance process, the report said.

The report recommended that the FDA establish a pediatric center within its device office to focus on pediatric issues. The FDA currently has a pediatric office of therapeutics but it mostly focuses on drugs.

The report also recommended the FDA work with children's hospitals to identify, evaluate and respond to possible problems with medical devices used in children.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com.