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Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):7164 [42CFR493.1252 (d); 493.1271 (b)] prohibits the use of expired reagents and other materials. The explanation given in this Federal Register is: “the manufacturer has the responsibility for establishing expiration dates that ensure the reagents and materials will perform properly when used for patient testing. In addition, any changes in the labeling of in-vitro diagnostics must comply with Food, Drug, and Cosmetic Act requirements.”
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