We, FDA, are providing you, establishments that make donor eligibility determinations for donors of human cells, tissues and cellular and tissue-based products (HCT/P Establishments), with updated recommendations concerning donor testing for evidence of Treponema pallidum (T. pallidum) infection, the etiologic agent of syphilis. As required under 21 CFR 1271.80(a) and (c) (§ 1271.80(a) and (c)), you must test a donor specimen for evidence of the communicable disease agents specified in 21 CFR 1271.85, including T. pallidum, using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer’s instructions, unless an exception to this requirement applies under 21 CFR 1271.90. This guidance clarifies that we do not consider cleared or approved diagnostic tests or pre-amendment devices (which have not been licensed, approved, or cleared) to be adequate for use in donor testing for T. pallidum infection under the criteria specified in § 1271.80(c).

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