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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 050 Date of Entry 09/17/2018 
FR Recognition Number 15-55
ASTM  F3259-17
Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds
1.1 This guide is a resource for conducting micro-computed tomography (microCT) imaging and analysis of porous scaffolds for tissue engineering applications. Considerations are provided for sample preparation, image acquisition parameter selection, post-processing, and data interpretation.
1.2 The information in this guide is intended to be applicable to products that include a porous scaffold component and are designed for tissue engineering repair strategies. The scaffolds may be fabricated from synthetic polymers (e.g., absorbable polyesters) or natural materials (e.g., calcium phosphates), mammalian or human derived materials (e.g., demineralized bone) or combinations of these. While some considerations are provided for imaging of materials that are of moderate to high radiodensity, specific guidelines are not provided for imaging metallic scaffolds.
1.3 Applicability of the guidelines herein will depend on scaffold material type and the user's application (e.g., experimental design, as manufactured characterization) as appropriate.
1.4 The guidelines for microCT discussed herein are most suitable for specimen scanning in vitro. Specific guidelines relevant to direct in vivo imaging of scaffolds are not included because the imaging parameters will be dependent on the implantation site, animal , breathing etc. In addition, consensus recommendations for in vivo imaging are provided in Bouxsein et al 2010 (1).2 While the specific imaging parameters and processing recommendations discussed in Bouxsein et al are specific to bone imaging, many of the considerations and precautions are also applicable for in vivo scaffold imaging.
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*
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 Contacts
 David Kaplan
 Carolyn Yong
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.