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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Entry 07/09/2014 
FR Recognition Number 15-40
Standard
ASTM  F2211-13
Standard Classification for Tissue Engineered Medical Products (TEMPs)
Scope/Abstract
1.1 This classification outlines the aspects of tissue engineered medical products that will be developed as standards. This classification excludes traditional transplantation of organs and tissues as well as transplantation of living cells alone as cellular therapies.

1.2 This classification 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.
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.
Relevant FDA Guidance and/or Supportive Publications*
Medical Devices Containing Materials Derived from Animal Sources (Except In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry; Final 1998

Draft Guidance: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage, July 17, 2007 (CBER and CDRH)

Guidance Document for Testing Biodegradable Polymer Implant Devices 1996.

Guidance for Industry Q5A Viral Evaluation of Biotechnology Products Devired From Cell Lines of Human or Animal Origin, September 1998

Draft Guidance for Industry and FDA Staff - Premarket Notification [510 (k)] Submissions for Medical Devices that Include Antimicrobial Agents, July 19, 2007

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 David Kaplan
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-2519
  david.kaplan@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Tissue Engineering
*These are provided as examples and others may be applicable.
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