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The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
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| Guidance for Industry
Revised Recommendations Regarding
Invalidation of Test Results of Licensed
and 510(k) Cleared Bloodborne
Pathogen Assays Used to Test Donors |
| Internet: | http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm062869.pdf |
| Origin/Publisher: | Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ |
| Content: | FDA now recommends implementation of quality assurance and quality control procedures that involve use of external control reagents beyond those provided by the test kit manufacturer in order to contribute to overall testing accuracy and therefore to blood safety. |
| Document Type: | Guidance for Industry |
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