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Zdrowie i gospodarka · 21/01/2003

Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing

The Food and Drug Administration (FDA) is further delaying, until January 21, 2004, the effective date for requiring establishments that engage in the recovery, screening, testing, processing, storage, or distribution of all human cells, tissues, and cellular and tissue- based products (HCT[sol]Ps) not currently regulated under section 361 of the Public Health Service Act (PHS Act) and part 1270 (21 CFR part 1270) to register with FDA and list their HCT[sol]Ps. FDA is taking this action to help ensure that the effective date for this rule is closer to the effective date of the anticipated finalization of the remaining proposed rules involving HCT[sol]Ps.

Source: Federal Register — Food and Drug AdministrationOpen original release →