Mobile Medical Applications
MedSun: Newsletter #63, August 2011

FDA Medical Devices: Products and Medical Procedures

Through draft guidance release on July 19, 2011 the FDA defined a small subset of mobile medical apps that may impact on the performance or functionality of currently regulated medical devices and as such, will require FDA oversight. The FDA encourages feedback from manufacturers, health care providers and others on how its proposal may support the balance between promoting innovation and assuring safety and effectiveness.

Additional Information:

FDA Medical Devices: Products and Medical Procedures. Mobile Medical Applications. July 25, 2011.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ucm255978.htm

FDA Consumer Update. FDA Proposes Health 'App' Guidelines. July 29, 2011.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm263332.htm


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