FDA begins full-scale eMDR launch

FDA is ready to begin accepting electronic medical device reporting submissions detailing adverse events from all company filers immediately, Office of Surveillance and Biometrics Director Susan Gardner says in a May 8 memo posted online May 20. However, firms should still contact FDA before they begin electronic submissions, according to the agency; details on eMDR are available at 1www.fda.gov/cdrh/emdr. The program, for which a pilot launched last year, will soon be mandatory (2"The Gray Sheet" Oct. 1, 2007, p. 19)