Form Fda 3356 PDF Details

The Form FDA 3356 is a crucial document managed by the Department of Health and Human Services, specifically within the Food and Drug Administration (FDA), tailored for establishments involved with Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). This comprehensive form is meticulously designed to facilitate the registration and listing of establishments engaged in the processing, recovery, storage, labeling, packing, or distribution of HCT/Ps. It also applies to entities focused on the screening or testing of cell or tissue donors. The form, which must be submitted in adherence to regulations laid out under 21 CFR Part 1271, 207.20, and 807.20, serves multiple purposes including initial registration, annual updates, modifications to existing information, or marking an establishment as inactive. The intricacies of the form span details such as establishment and HCT/P information, including physical and mailing addresses, U.S. agent details for non-U.S. establishments, and specific types and functions of the HCT/Ps managed. Furthermore, it includes a section for proprietary names and requires explicit details regarding the establishment’s activities, whether it be recovery, processing, storage, or distribution of HCT/Ps. The necessity for accurate completion and the declaration by the reporting official underlines the form’s importance in maintaining up-to-date and factual records within the FDA’s regulatory landscape. This process not only ensures compliance with federal regulations but also supports the FDA’s mission to protect public health by supervising cell and tissue-based products, guaranteeing they are safe, effective, and available to those in need.

QuestionAnswer
Form NameForm Fda 3356
Form Length2 pages
Fillable?No
Fillable fields0
Avg. time to fill out30 sec
Other namespreprinted, Allogeneic, Rockville, CFR

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Rockville completion process outlined (stage 1)

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Completing segment 2 in Rockville

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