Cordis Corp.

Company: Cordis Corp.
Product: “Cypher Sirolimus-Eluting Coronary Stent”
Date: 4/1/04

Failure to adequately validate for its intended purpose and according to an established protocol computer software used as part of the production or quality system, and failure to document validation activities and results, as required by 21 CFR 820.70(i).

The automated _____ data acquisition system, used to ensure the integrity of the analytical data generated from laboratory chromatography equipment, was not adequately validated for its intended use. The validation did not include testing and verification of backup and restoration of the electronic data files.

Issuer: Center for Devices and Radiological Health (CDRH)

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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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