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GUIDANCE DOCUMENT

"Computer Crossmatch" (Computerized Analysis of the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type); Guidance for Industry April 2011

Final

"Computer Crossmatch" (Computerized Analysis of the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type);

Docket Number:
FDA-2007-D-0019
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

"Computer crossmatch" is a process used to ensure that blood released for transfusion is compatible with the intended recipient.1  We, FDA, are issuing this guidance to assist you, blood establishments that perform compatibility testing using a computer crossmatch system to perform computerized matching of blood, consistent with current good manufacturing practice (CGMP) requirements in 21 CFR Parts 210, 211 and 606. Blood establishments must have standard operating procedures (SOPs) "to demonstrate incompatibility between the donor’s cell type and the recipient’s serum or plasma type" under the compatibility testing requirements in 21 CFR 606.151(c). This guidance describes practices that we believe satisfy the requirements in 21 CFR 606.151(c) to help ensure detection of an incompatible crossmatch when using a computerized system for matching a donor’s cell type with a recipient’s serum or plasma type.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2007-D-0019.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010