• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 028 Date of Recognition 03/16/2012 
FR Recognition Number 15-35
ASTM F2900-11
Standard Guide for Characterization of Hydrogels used in Regenerative Medicine
1.1 Hydrogels are water-swollen polymeric networks that retain water within the spaces between the macromolecules; and maintain the structural integrity of a solid due to the presence of cross-links (1-3).2 They are mainly used in regenerative medicine as matrix substitutes, delivery vehicles for drugs and/or biologics, and environments for cell culture. In these applications, hydrogel efficacy may depend on the ability to: support the permeation of dissolved gases, nutrients and bioactive materials; sustain cell growth and migration; degrade; release drugs and/or biologics at an appropriate rate; and maintain their shape.

1.2 Hydrogels used in regenerative medicine can be composed of naturally derived polymers (for example, alginate, chitosan, collagen (4, 5)), synthetically derived polymers (for example, polyethylene glycol (PEG), polyvinyl alcohol (PVA) (4, 5)) or a combination of both (for example, PVA with chitosan or gelatin (6)). In clinical use, they can be injected or implanted into the body with or without the addition of drugs and/or biologics (7).

1.3 This guide provides an overview of test methods suitable for characterizing hydrogels used in regenerative medicine. Specifically, this guide describes methods to assess hydrogel biological properties, kinetics of formation, degradation and agent release, physical and chemical stability and mass transport capabilities are discussed.

1.4 The test methods described use hydrated samples with one exception: determining the water content of hydrogels requires samples to be dried. It is generally recommended that hydrogels that have been dried for this purpose are not rehydrated for further testing. This recommendation is due to the high probability that, for most hydrogel systems, the drying-rehydration process can be detrimental with possible alterations in structure.

1.5 This guide does not consider evaluation of the microstructure of hydrogels (for example, matrix morphology, macromolecule network structure and chain conformation).

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
The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles: Final Guidance for FDA and Industry 2002

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

Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; March 1999

Guidance Document for Dura Substitute Devices; Final Guidance for Industry 2000
FDA Technical Contact
 David Kaplan
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Tissue Engineering