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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 028 Date of Entry 03/16/2012 
FR Recognition Number 15-30
Standard
ASTM F2212-11 Standard Guide for Characterization of Type I Collagen as a Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPS)
Scope/Abstract
1.1 This guide for characterizing collagen-containing biomaterials is intended to provide characteristics, properties, and test methods for use by producers, manufacturers, and researchers to more clearly identify the specific collagen materials used. With greater than 20 types of collagen and the different properties of each, a single document would be cumbersome. This guide will focus on the characterization of Type I collagen, which is the most abundant collagen in mammals, especially in skin and bone. Collagen isolated from these sources may contain other types of collagen, for example, Type III and Type V. This guide does not provide specific parameters for any collagen product or mix of products or the acceptability of those products for the intended use. The collagen may be from any source, including, but not limited to, animal or cadaveric sources, human cell culture, or recombinant sources. The biological, immunological, or toxicological properties of the collagen may vary, depending on the source material. The properties of the collagen prepared from each of the above sources must be thoroughly investigated, as the changes in the collagen properties as a function of source materials is not thoroughly understood. This guide is intended to focus on purified Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs); some methods may not be applicable for gelatin or tissue implants. This guide may serve as a template for characterization of other types of collagen.

1.2 The biological response to collagen in soft tissue has been well documented by a history of clinical use (1, 2)2 and laboratory studies (3, 4, 5, 6). Biocompatibility and appropriateness of use for a specific application(s) is the responsibility of the product manufacturer.
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.
Transition Period
FDA recognition of ASTM F2122-11 [Rec# 15-30] will be superseded by recognition of ASTM F2122-19 [Rec# 15-60]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 15-30] until July 11, 2021. After this transition period, declarations of conformity to [Rec# 15-30] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
This standard is relevant for medical devices/combination products where tissue engineering is a component of the development and manufacture of the product.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Medical Devices Containing Materials Derived from Animal Sources (Except In Vitro Diagnostic Devices), Issued March 2019.

Guidance for Industry and FDA Staff: The Least Burdensome Provisions:Concept and Principles, Issued February 2019.

Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage, Issued December 2011 (CBER and CDRH).

Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh, Issued March 1999.

Guidance for Industry: Guidance Document for Dura Substitute Devices, Issued 2000.

Guidance for Industry and FDA Staff: Surgical Sutures - Class II Special Controls, Issued June 2003.
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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