Regulatory Focus™ > News Articles > FDA Finalizes Guidance on Donor Screening for Syphilis Infection

FDA Finalizes Guidance on Donor Screening for Syphilis Infection

Posted 09 September 2015 | By Michael Mezher 

FDA Finalizes Guidance on Donor Screening for Syphilis Infection

The US Food and Drug Administration (FDA) has finalized its guidance to establishments that screen human tissue and cell donors for various communicable diseases on screening for Treponema pallidum, commonly known as syphilis.


Under 21 CFR 1271.80, establishments that screen donors of human cells, tissues and cellular and tissue-based products (HCT/P establishments) are required to screen for specific diseases, such as syphilis, human immunodeficiency virus (HIV) and hepatitis B and C.

Specifically, 21 CFR 1271.80(c) states that donors must be screened for syphilis using "appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases."

When FDA's previous guidance for these establishments was released in 2007, the agency had not licensed or cleared many donor screening tests for syphilis. Because of this, HCT/P establishments asked FDA for additional leeway, claiming that it would be "overly burdensome" to switch from serological tests to donor screening tests.

As a result, in the 2007 guidance, the agency said it considered "FDA-cleared diagnostic serological tests to be adequate for use in donor screening for syphilis."

New Guidance

In the years since 2007, FDA has cleared additional donor screening tests for detecting syphilis. The agency says it believes cleared tests for syphilis screening are "widely available, and that laboratories now are proficient in their ability to use such systems."

As such, the agency says it can "no longer support a policy for the use of diagnostic syphilis tests for use as a donor screening test," and will "enforce the requirements" of 21 CFR 1271.80(c) which state donor screening tests must be used.

Additionally, FDA is now explicitly stating that pre-amendment devices, or devices marketed for the same indication from before 28 May 1976, are "not acceptable for use as a donor screening test for … T. pallidum."

FDA is asking all HCT/P establishments to comply with the new guidance within six months.


FDA Guidance


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