United States: FDA Releases Draft Guidance On "Software As A Medical Device" - Day Pitney LLP
Wednesday, 23 November 2016 On October 14, the U.S. Food and Drug Administration (FDA) released draft guidance entitled "Software as a Medical Device (SaMD): Clinical Evaluation" and invited interested parties to submit comments for consideration in the final version.
Doctors are testing a device that would let women do part of their breast construction at home. It’s not only aimed at making treatment more comfortable and convenient, but also giving a sense of control to women who’ve had a breast removed. (Nov. 16)