02
Sep
2003

ARC Consent Decree Correspondence – Fines

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ARC Consent Decree Correspondence
September 2, 2003

The ARC consent decree from May 2003 includes many provisions related to computer systems as well as other aspects of compliance. The correspondence at the link provided states the fines FDA is assessing for ARC’s inadequate response to one of the consent decree requirements which related to revamping their problem management procedures.

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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