TITLE

FDA's New Guidance on Wireless Medical Devices

AUTHOR(S)
Lincoln, John E.
PUB. DATE
September 2013
SOURCE
Journal of Validation Technology;Sep2013, Vol. 19 Issue 3, p1
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
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.
ACCESSION #
95415179

 

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