IEC 82304 and other FDA newly recognized standards

The FDA published a list of standards added to their recognition list on August 21, 2017. IEC 82304-1 Edition 1.0 2016-10. Health software part 1: General requirements for product safety are included on this list in the Software/Informatics Section, along with a number of other standards related to device communication (including specifics of glucose meters and insulin pumps), and Cybersecurity.

The full FDA list of newly recognized standards is at the link provided. Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 047

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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