Congressional hearing on SW as a Device

The link provided is to an article on mobihealthnews.com summarizing the congressional hearing last week on whether software should be regulated by FDA as a medical device. This is related to the Blackburn Bill which would exempt many standalone software medical applications, if passed into law, from FDA regulation.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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