Cfr 1271.10
WebApr 6, 2024 · regulation under 21 CFR Part 1271, issued under the authority of section 361 of the Public Health Service Act (PHS Act) [42 U.S.C. 264]. HCT/Ps that do not meet all the criteria in 21 CFR 1271.10 ... Web2 21 CFR 1271.10(a) 3 The preamble to the final rule states that some “drugs or devices that have as their principal purpose sterilizing, preserving, or storage may also have a therapeutic ...
Cfr 1271.10
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Web§ 1271.400 Inspections. ( a) If you are an establishment that manufactures HCT/Ps described in § 1271.10, whether or not under contract, you must permit the Food and Drug Administration (FDA) to inspect any manufacturing location at any reasonable time and in a reasonable manner to determine compliance with applicable provisions of this part. WebProvides the text of the 21 CFR 1271.10 - Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do? (CFR). 21 CFR 1271.10 - Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?
WebeCFR :: 12 CFR 1271.10 -- Transfer of funds between Banks. eCFR The Electronic Code of Federal Regulations Title 12 Displaying title 12, up to date as of 2/15/2024. Title 12 was last amended 2/08/2024. view historical versions Title 12 Chapter XII Subchapter D Part 1271 Subpart B § 1271.10 Previous Next Top eCFR Content Webrules and regulations or that the HCT/P is licensed or approved by FDA (21 CFR 1271.27(b)). Proprietary Name(s) Establishment Functions HCT/P(s) FEI: 1000113913 Legal Name: VIVEX Biologics, Inc. Testing For Micro-Organisms Only: No FOOD AND DRUG ADMINISTRATION Blood: Drugs: Other FDA Registrations: Legal Name and …
WebUnder the second scheme, if a cellular therapy product does not meet all the criteria in 21 CFR 1271.10 (a) it is regulated as a drug, device, and/or biological product under the Federal Food, Drug, and Cosmetic Act (FDCA) and Section 351 of the PHS Act, and as such is commonly referred to as a "351 product." WebNavigate by entering citations or phrases (eg: 1 CFR 1.1 49 CFR 172.101 Organization and Purpose 1/1.1 Regulation Y FAR). Choosing an item from citations and headings will bring you directly to the content. Choosing an item from full text search results will bring you to those results. Pressing enter in the search box will also bring you to ...
Web21 CFR Part 1271 if it meets all of the following criteria under 21 CFR 1271.10(a): 1. The HCT/P is minimally manipulated; 2.
Web1271.145 – 1271.320. § 1271.145. Prevention of the introduction, transmission, or spread of communicable diseases. § 1271.150. Current good tissue practice requirements. § 1271.155. Exemptions and alternatives. § 1271.160. Establishment and maintenance of a quality program. free dbd unlockerWebfound in 21 CFR Part 1271. In 21 CFR 1271.10, the regulations identify the criteria for regulation solely under section 361 of the PHS Act and 21 CFR Part 1271. An HCT/P is regulated solely under section 361 of the PHS Act and 21 CFR Part 1271 if it meets all of the following criteria (21 CFR 1271.10(a)): 1) The HCT/P is minimally manipulated; freed beeches worksopWebJan 1, 2015 · 21 CFR 1271.10(a) sets out the criteria that form the foundation of our tiered, risk-based approach to regulating HCT/Ps. HCT/Ps that meet all of these criteria are regulated solely under section ... freedb database