federal_register: 2022-23573
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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022-23573 | Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Small Entity Compliance Guide; Availability | Rule | The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled "Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps): Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entity establishments that manufacture HCT/Ps better understand the comprehensive regulatory framework for HCT/Ps set forth in the regulations and comply with certain HCT/P- related final rules. The SECG announced in this notice supersedes the SECG of the same title dated August 2007. | 2022-11-01 | 2022 | 11 | https://www.federalregister.gov/documents/2022/11/01/2022-23573/regulation-of-human-cells-tissues-and-cellular-and-tissue-based-products-small-entity-compliance | https://www.govinfo.gov/content/pkg/FR-2022-11-01/pdf/2022-23573.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled "Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps): Small Entity Compliance Guide." The small entity... |