501(k)

By  Brian Dolan 08:41 am August 24, 2009
By Bradley Merrill Thompson, Partner, Epstein Becker & Green, P.C. Last month I outlined the triggers that could cause an ordinary mobile phone to become an FDA-regulated medical mobile phone. This month, in the second of six planned articles, I will outline the FDA requirements that would apply to a mobile phone that crosses that line. To summarize the July 13 article on "FDA may regulate...