Separation Technology Centrifuges

Separation Technology 3/7/97 Centrifuges

4. Failure to document, review, approve, and validate changes to components, finished devices, labeling, packaging or manufacturing process specifications [21 CFR 820.100(b)(1),(2) & (3)], e.g., there is no documentation of the prior approval of the software specification change initiated 1/24/97 that was an attempt to correct the failures described above. Also, there is no change validation to assure the software modifications will correct the failure mode.

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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