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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 028 Date of Recognition 03/16/2012 
FR Recognition Number 15-36
Standard
ASTM F2383-11
Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)
Scope/Abstract
1.1 This guide is intended as a resource for individuals and organizations involved in the production, delivery, and regulation of tissue engineered medical products (TEMPs). The safety from contamination by potentially infectious adventitious agents is important in the development of all TEMPs as well as their components. This guide addresses how to assess safety risks associated with adventitious agents and their byproducts. These agents currently include bacteria, fungi, mycoplasma, viruses, endotoxins, transmissible spongiform encephalopathies (TSEs), and parasitic organisms. This guide does not address TEMPs with live animal cells, tissues or organs, or human cells, including stem cells, grown on any animal feeder cells. Also excluded is patient follow-up testing.

1.2 This guide does not apply to any medical products of human origin regulated by the U.S. Food and Drug Administration under 21 CFR Parts 16 and 1270 and 21 CFR Parts 207, 807 and 1271. This guide does apply to cellular therapies regulated under the PHS (Public Health Service) act.

Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
§1270 Human Tissue Intended for Transplantation
§1271 Human Cells, Tissues, and Cellular and Tissue-Based Products
§210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs, General
§211 Current Good Manufacturing Practice for Finished Pharmaceuticals
§820 Quality System Regulation
§610.12 General Biological Products Standards- Sterility
§610.13 (b) General Biological Products Standards- Purity Tests for Pyrogenic Substances
Relevant FDA Guidance and/or Supportive Publications
Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs), 2008

Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products, 2008
Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products, 2007

Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cellular, Tissues and Cellular-Based Products, 2009

Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps), 2009

Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for Transplantation, 2002

Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps), 2009

Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy, 1998
FDA Technical Contacts
 Judith Arcidiacono
  FDA/OMPT/CBER/OTAT/
  240-402-8250
  judith.arcidiacono@fda.hhs.gov
 Kimberly Benton
  FDA/OMPT/CBER/OTAT/
  204-402-8258
  kimberly.benton@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Tissue Engineering
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