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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 of CDRH’s Office of Surveillance and Biometrics, said.
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