Radia Industry Sterilization of plasma separators

Radia Industry Co. 6/3/97 Sterilization of plasma separators

1. Failure to conduct processing control operations in a manner designed to assure that the device conforms to applicable specifications, as required by 21 CFR 820.100(b)(2). For example, there was also an incorrect maximum conveyor speed observed on February 24, 1997, by the investigator and one member of the firm. An operator is required to manually change the upper and lower limits of the speed to insure that the correct absorbed dose is delivered. The computer software is supposedly designed to prompt the operator when a change in conveyor speed is necessary.

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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