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A Section 1271.80 (c) requires
only two items 1) that FDA-approved or cleared donor
screening tests are used and 2) that the tests are performed
"by a laboratory that either is certified to perform such
testing on human specimens under the Clinical Laboratory
Improvement Amendments of 1988" or has met equivalent
requirements as determined by CMMS. Section 1271.1 of the
regulations states that if you "manufacture" donor tissue
you must be registered. The definition of "manufacturer" in
Section 1271.3 (e) includes if you do ANY of the following:
recovery, processing, storage, labeling, packaging,
distribution, screening or testing. One portion of Good
Tissue Practices (GTP; Subpart D (1271.150(c))) that applies
to reproductive tissue states that we must ensure that any
group we contract with to perform any steps (like testing)
also complies with the GTP requirements. This means that in
addition to the two required items above, we must also make
sure the laboratory is FDA registered and we should also
regularly audit these companies and make sure that we have
contracts with them stating that they will only use the
proper FDA approved tests in the approved manner.
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