{"id":1888,"date":"2025-05-23T15:33:31","date_gmt":"2025-05-23T07:33:31","guid":{"rendered":"https:\/\/vcro.com.tw\/?p=1888"},"modified":"2025-06-16T16:50:32","modified_gmt":"2025-06-16T08:50:32","slug":"u-s-fda-releases-updated-guidance-on-donor-eligibility-determination-for-hct-ps-part-1","status":"publish","type":"post","link":"https:\/\/www.vcro.com.tw\/?p=1888","title":{"rendered":"U.S. FDA releases updated guidance on donor eligibility determination for HCT\/Ps (Part 1.)"},"content":{"rendered":"\n<p>In January 2025, the U.S. Food and Drug Administration (FDA) released six updated guidance documents about donor eligibility determinations for human cells, tissues, and cellular and tissue-based products (HCT\/Ps). These updates replace and expand upon the 2007 guidance<sup>1<\/sup> on donor eligibility determination, reflecting the current interpretation of regulatory requirements under 21 CFR Part 1271 Subpart C. The updated documents include one comprehensive draft guidance titled <em>Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products<\/em><em>: Draft Guidance for Industry<sup>2<\/sup><\/em>, as well as five RCDAD-specific guidance documents<sup>3-7<\/sup>. These guidance documents outline the FDA\u2019s current recommendations on risk factor assessments, relevant clinical evidence, and physical evidence for relevant communicable disease agents or diseases (RCDAD), aiming to reduce the risk of communicable disease transmission. The five finalized or draft guidance specifically address the following RCDADs, including Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Sepsis, and <em>Mycobacterium tuberculosis<\/em> (Mtb).<\/p>\n\n\n\n<p>The guidance documents for sepsis and Mtb are effective immediately, while the remaining documents are currently pending finalization. Additionally, the FDA has consolidated previous guidance documents issued between 2007 and 2025 related to syphilis, HBV, and West Nile Virus (WNV), incorporating updates to recommended testing methodologies. The updated information is summarized below:<\/p>\n\n\n\n<p><strong>1. Updated RCDADs<\/strong><\/p>\n\n\n\n<p>The FDA has revised the list of RCDADs for which both donor screening and testing are required. All types of HCT\/Ps donors must be screened and tested for:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>HIV (HIV-1 and HIV-2)<\/li>\n\n\n\n<li>HBV and HCV<\/li>\n\n\n\n<li>Syphilis<\/li>\n\n\n\n<li>Transmissible spongiform encephalopathy (TSE)<\/li>\n\n\n\n<li>West Nile Virus (WNV)<\/li>\n\n\n\n<li>Vaccinia virus<\/li>\n\n\n\n<li>Sepsis<\/li>\n\n\n\n<li><em>Mycobacterium tuberculosis <\/em>(Mtb)<\/li>\n\n\n\n<li>Agents of xenotransplantation-associated infection risk<\/li>\n<\/ul>\n\n\n\n<p>For leukocyte-rich HCT\/Ps, additional screening and testing for human T-lymphotropic virus types I and II (HTLV-1\/2) and cytomegalovirus (CMV) are required.<\/p>\n\n\n\n<p>For reproductive HCT\/Ps, <em>Chlamydia trachomatis<\/em> and <em>Neisseria gonorrhea<\/em> are identified as RCDADs and require appropriate donor screening and testing.<\/p>\n\n\n\n<p>It is noteworthy that the Zika virus, previously identified as an RCDAD in 2016, was removed from the list in 2024 due to significantly decreased incidence and prevalence.<\/p>\n\n\n\n<p><strong>Reference<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT\/Ps): Guidance for Industry 2007<\/li>\n\n\n\n<li>Recommendations for determining donor eligibility of donors of human cells, tissues and cellular and tissue-based products: Draft Guidance for Industry 2025<\/li>\n<\/ol>\n\n\n\n<figure class=\"wp-block-gallery has-nested-images columns-default is-cropped wp-block-gallery-1 is-layout-flex wp-block-gallery-is-layout-flex\">\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"1024\" data-id=\"1882\" src=\"https:\/\/www.vcro.com.tw\/wp-content\/uploads\/2025\/04\/U.S.-FDA-Releases-Draft-Guidance-on-Expedited-Program-for-Serious-Conditions-Accelerated-Approval-of-Drugs-and-Biologics-Part-3.png\" alt=\"VCRO Industry News U.S. FDA Releases Draft Guidance on Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics (Part 3.)\" class=\"wp-image-1882\" srcset=\"https:\/\/www.vcro.com.tw\/wp-content\/uploads\/2025\/04\/U.S.-FDA-Releases-Draft-Guidance-on-Expedited-Program-for-Serious-Conditions-Accelerated-Approval-of-Drugs-and-Biologics-Part-3.png 1024w, https:\/\/www.vcro.com.tw\/wp-content\/uploads\/2025\/04\/U.S.-FDA-Releases-Draft-Guidance-on-Expedited-Program-for-Serious-Conditions-Accelerated-Approval-of-Drugs-and-Biologics-Part-3-300x300.png 300w, https:\/\/www.vcro.com.tw\/wp-content\/uploads\/2025\/04\/U.S.-FDA-Releases-Draft-Guidance-on-Expedited-Program-for-Serious-Conditions-Accelerated-Approval-of-Drugs-and-Biologics-Part-3-150x150.png 150w, https:\/\/www.vcro.com.tw\/wp-content\/uploads\/2025\/04\/U.S.-FDA-Releases-Draft-Guidance-on-Expedited-Program-for-Serious-Conditions-Accelerated-Approval-of-Drugs-and-Biologics-Part-3-768x768.png 768w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><figcaption class=\"wp-element-caption\">VCRO Industry News U.S. FDA Releases Draft Guidance on Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics (Part 3.)<\/figcaption><\/figure>\n<\/figure>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In January 2025, the U.S. Food and Drug Administration (FDA) released six updated guidance documents about donor eligibility determinations for human cells, tissues, and cellular and tissue-based products (HCT\/Ps). These updates replace and expand upon the 2007 guidance1 on donor eligibility determination, reflecting the current interpretation of regulatory requirements under 21 CFR Part 1271 Subpart [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":1882,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11],"tags":[30,49,46,50,48,52,47,51],"class_list":["post-1888","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-industry-news","tag-fda","tag-hbv","tag-hct-ps","tag-hcv","tag-hiv","tag-mycobacterium-tuberculosis","tag-rcdads","tag-sepsis"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>U.S. FDA releases updated guidance on donor eligibility determination for HCT\/Ps (Part 1.) - VCRO<\/title>\r\n<meta name=\"description\" content=\"U.S. FDA releases updated guidance on donor eligibility determination for HCT\/Ps (Part 1.) VCRO Industry news - In January 2025, the U.S. Food and Drug Administration (FDA) released six updated guidance documents about donor eligibility determinations for human cells, tissues, and cellular and tissue-based products (HCT\/Ps). These updates replace and expand upon the 2007 guidance1 on donor eligibility determination, reflecting the current interpretation of regulatory requirements under 21 CFR Part 1271 Subpart C.\" \/>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.vcro.com.tw\/?p=1888\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:title\" content=\"U.S. FDA releases updated guidance on donor eligibility determination for HCT\/Ps (Part 1.) - VCRO\" \/>\r\n<meta property=\"og:description\" content=\"U.S. FDA releases updated guidance on donor eligibility determination for HCT\/Ps (Part 1.) VCRO Industry news - In January 2025, the U.S. Food and Drug Administration (FDA) released six updated guidance documents about donor eligibility determinations for human cells, tissues, and cellular and tissue-based products (HCT\/Ps). These updates replace and expand upon the 2007 guidance1 on donor eligibility determination, reflecting the current interpretation of regulatory requirements under 21 CFR Part 1271 Subpart C.\" \/>\r\n<meta property=\"og:url\" content=\"https:\/\/www.vcro.com.tw\/?p=1888\" \/>\r\n<meta property=\"og:site_name\" content=\"VCRO\" \/>\r\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/people\/\/100057388670681\/\" \/>\r\n<meta property=\"article:published_time\" content=\"2025-05-23T07:33:31+00:00\" \/>\r\n<meta property=\"article:modified_time\" content=\"2025-06-16T08:50:32+00:00\" \/>\r\n<meta property=\"og:image\" content=\"https:\/\/www.vcro.com.tw\/wp-content\/uploads\/2025\/04\/U.S.-FDA-Releases-Draft-Guidance-on-Expedited-Program-for-Serious-Conditions-Accelerated-Approval-of-Drugs-and-Biologics-Part-3.png\" \/>\r\n\t<meta property=\"og:image:width\" content=\"1024\" \/>\r\n\t<meta property=\"og:image:height\" content=\"1024\" \/>\r\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\r\n<meta name=\"author\" content=\"editor vcro\" \/>\r\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\r\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"editor vcro\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\r\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.vcro.com.tw\/?p=1888#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.vcro.com.tw\/?p=1888\"},\"author\":{\"name\":\"editor vcro\",\"@id\":\"https:\/\/www.vcro.com.tw\/#\/schema\/person\/6c5a6d51ce913bb482b9fe29aeefbdfc\"},\"headline\":\"U.S. FDA releases updated guidance on donor eligibility determination for HCT\/Ps (Part 1.)\",\"datePublished\":\"2025-05-23T07:33:31+00:00\",\"dateModified\":\"2025-06-16T08:50:32+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.vcro.com.tw\/?p=1888\"},\"wordCount\":405,\"publisher\":{\"@id\":\"https:\/\/www.vcro.com.tw\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.vcro.com.tw\/?p=1888#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.vcro.com.tw\/wp-content\/uploads\/2025\/04\/U.S.-FDA-Releases-Draft-Guidance-on-Expedited-Program-for-Serious-Conditions-Accelerated-Approval-of-Drugs-and-Biologics-Part-3.png\",\"keywords\":[\"FDA\",\"HBV\",\"HCT\/Ps\",\"HCV\",\"HIV\",\"Mycobacterium tuberculosis\",\"RCDADs\",\"Sepsis\"],\"articleSection\":[\"Industry news\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.vcro.com.tw\/?p=1888\",\"url\":\"https:\/\/www.vcro.com.tw\/?p=1888\",\"name\":\"U.S. FDA releases updated guidance on donor eligibility determination for HCT\/Ps (Part 1.) - VCRO\",\"isPartOf\":{\"@id\":\"https:\/\/www.vcro.com.tw\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.vcro.com.tw\/?p=1888#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.vcro.com.tw\/?p=1888#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.vcro.com.tw\/wp-content\/uploads\/2025\/04\/U.S.-FDA-Releases-Draft-Guidance-on-Expedited-Program-for-Serious-Conditions-Accelerated-Approval-of-Drugs-and-Biologics-Part-3.png\",\"datePublished\":\"2025-05-23T07:33:31+00:00\",\"dateModified\":\"2025-06-16T08:50:32+00:00\",\"description\":\"U.S. FDA releases updated guidance on donor eligibility determination for HCT\/Ps (Part 1.) 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