FDA Public Workshop on Home Use of Medical Devices (May 24)
This post was written by Paul Sheives.
FDA is holding a public workshop entitled “Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of Medical Device Technology Migrating into the Home,” on May 24, 2010 in Silver Spring, MD. The purpose of the workshop is to seek input from interested parties regarding the issues raised by the use of medical device technology in the home environment. More specifically, FDA seeks input on: (1) the agency’s definition of “home use”; (2) the unique risks of the home environment; (3) the unique characteristics of end users in the home environment; (4) issues with tracking home use devices for the purpose of safety notices and recalls; and (5) device labeling issues for home use. FDA is accepting comments relating to the workshop until June 30, 2010, and registration for attendance closes May 17, 2010.
