FDA guideline for QA in blood establishments

FDA CBER “Guideline for quality assurance in blood establishments” issued July 11, 1995.This guideline applies to the Blood Establishments but has information that can be useful to blood bank Computer System manufacturers. The purpose of this guideline is to assist manufacturers of Blood and blood components, including blood banks, transfusion services, and plasmapheresis centers, in developing a qualityassurance (QA) program in their effort to be consistent with recognized principles of quality assurance and current good manufacturing practice (CGMP).

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

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.