The QMN Weekly Bulletin
Aug. 24, 2012 | Vol. 4 No. 34
FDA Beefing Up MedTech Surveillance Computer Toolkit
The FDA expects to pilot a mobile version of the MedWatch reporting form on hand-held devices by the end of this year, one of several new software tools the agency is developing to improve postmarket monitoring of adverse events.
The mobile app is currently being refined by the FDA, Columbia University and Boston Children’s Hospital to ensure it collects the best possible information on device-related incidents, Thomas Gross, director CDRH’s Office of Surveillance and Biometrics, said at the Food & Drug Law Institute’s Medical Device Regulation and Litigation Conference in Washington, D.C.
Obviously, this medical app will be FDA approved, but what about the 40,000 other applications on the market?
Currently, the FDA has proposed policing only those apps that use supplemental attachments to transform a mobile platform into a medical device and others that act as accessories to an already regulated medical device. But that could change.
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