FDA Standards Recogniton List Update April 2016

FDA updated their list of Recognized Standards April 4, 2016. The full list is at the link provided. There were several updates related to software standards as listed below. The new edition of IEC 62304 1.1 2015-06 replaces the prior edition. The new 2014-2015 edition of IEEE 11073-20601 Personal Health Data communication replaces the previous 2010 edition.

In additon, there was one new standard recognized related to tsoftware. IEEE 11073-10419:2015 for Personal Health device communication for insulin pumps.

SoftwareCPR experts including those involved in development of IEC 62304 and its first Amendment are available to provide guidance on its implementation as well as training.

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