Irwin Memorial Blood Centers Blood Center

Irwin Memorial Blood Centers 3/20/97 Blood Center

Please be advised that the agency’s memorandum dated April 6, 1988, entitled “Recommendations for Implementation of Computerization in Blood Establishments” indicates as a data security issue that “if key elements of the database are changed, these changes should be traceable as to the time and person making the changes so that integrity and reproducibility of data are assured.” In addition, the agency’s memorandum dated September 8, 1989, “Requirements for Computerization of Blood Establishments” states that among other requirements, “Security procedures to prevent unauthorized entry and physical access to the computer system” and “Procedure for control of changes in hardware/software” must be incorporated into SOPs. Copies of both these memoranda were provided to your firm with the Warning Letter dated January 13, 1993 and are enclosed with this letter.

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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