FDA's New Guidance on Wireless Medical Devices

Lincoln, John E.
September 2013
Journal of Validation Technology;Sep2013, Vol. 19 Issue 3, p1
Academic Journal
The article focuses on the guidance document on wireless medical devices of the U.S. Food & Drug Administration (FDA). It states that the guide focuses on two important sections including considerations for design and recommendations for premarket submissions for devices with radio frequency (RF) wireless technology. It mentions that it recommends that labeling must include all information outlined in appropriate reference standards.


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