Establishment e- xmatch FDA Approval/ Status

Status of FDA permission requirements for Blood Bank establishment use of electronic crossmatch as of November 18, 1999:

Because 21 CFR 606.151 requires a serologic crossmatch those hospitals (all
hospitals) who wish to use the electronic crossmatch must apply for a
variance to 21 CFR 606.151 (as allowed by 21 CFR 640.120) to gain written
permission from FDA prior to implementation. At this time, we review their
validation prior to approving the variance. Since everyone is legally
required to follow the CFR, this rule applies to everyone. To use the
electronic crossmatch without written FDA approval of the variance is
breaking the law.

But, things are changing. There is a change in 21 CFR 606.151 in process
now which would redefine the “crossmatch” in a way that the request for a
variance would no longer be necessary; however, it is unclear when this
change will be effective. When, and if the change is finalized, the
on-site validation would be performed and the records kept on site. Those
validation records would be examined by the FDA investigator during the next
routine inspection. Transfusion services which are not inspected by the FDA
should have those validation records inspected during the next HCFA
inspection [by a Memorandum of Understanding with HCFA, they are supposed to
inspect against CFR rules on behalf of FDA].

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