Hyman Phelps and McNamara
Firm Publications

What Happens to Medical Device Reports Once They Reach FDA?
January 2011

Ever wonder what happens to the thousands of medical device reports that are
filed every month with FDA? Are they being put to good use?

In October 2009, the HHS Office of Inspector General(OIG) issued a report
titled, "Adverse Event Reporting for Medical Devices. This report demonstrates
that the current system of medical device adverse event reporting, particularly
with regard to malfunction reports, could largely be considered a waste of industry and FDA resources.

Click here to view the full MD+DI Article

If you have any questions regarding the above information, please contact:
Jeffrey K. Shapiro (202) 737-9633 jshapiro@hpm.com