GE Consent Decree Letter to Customers

In January 2007 GE sent a letter to customers regarding recent FDA enforcement actions resulting in a stop shipment and Consent Decree. The letter is at the link provided. Some of the issues leading to this relatd to recalls in which software was part fo the cause or corrective action. GE announcements on this are posted on our recall page along with the initial FDA recall notifications.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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