federal_register: 2017-18737

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2017-18737 Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled "Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271; Guidance for Industry." The guidance document provides establishments that manufacture non-reproductive human cells, tissues, and cellular and tissue-based products (HCT/Ps), regulated solely under the Public Health Service Act (PHS Act) and under FDA regulations, with recommendations and relevant examples for complying with the requirements to investigate and report HCT/P deviations. The guidance announced in this notice finalizes the draft guidance of the same title dated December 2015. 2017-09-07 2017 9 https://www.federalregister.gov/documents/2017/09/07/2017-18737/deviation-reporting-for-human-cells-tissues-and-cellular-and-tissue-based-products-guidance-for https://www.govinfo.gov/content/pkg/FR-2017-09-07/pdf/2017-18737.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled "Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service...  

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