FDA Releases for Comment Draft Guidance for Industry Regarding Syphilis 

The FDA announced in the November 5, 2013, Federal Register, the availability for comment of a new draft Guidance for Industry: “Use of Donor Screening Tests To Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection with Treponema pallidum (T. pallidum) (Syphilis). Click to view a copy of the Federal Register notice and the Guidance for Industry. 

The draft guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps with updated recommendations concerning donor testing for evidence of T. pallidum infection, the etiologic agent of Syphilis. 

HCT/P establishments are required under Federal regulations to test a donor specimen for evidence of T. pallidum infection using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer’s instructions, unless an exception to this requirement applies. 

The draft guidance clarifies that FDA does not consider diagnostic tests or pre-amendment devices that have not been licensed, approved, or cleared to be adequate for use in donor testing for T. pallidum infection. 

When finalized, this guidance will supersede the recommendations for testing donors for Syphilis that were published in the 2007 Donor Eligibility Guidance for Industry. 

Comments on the draft will be accepted through February 3, 2014. Electronic comments should be submitted to http://www.regulations.gov or written comments should be directed to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Please forward a copy of your comments to the (CRB or NILA) office.