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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 066 Date of Entry 05/25/2026 
FR Recognition Number 8-650
Standard
ASTM  F3766-25
Standard Guide for Content and Format of Test Report Summaries for Medical and Surgical Materials and Device Standards
Scope/Abstract
1.1 This guide provides general principles for generating a test report summary that presents results obtained using a standard for medical and surgical devices and materials, and it recommends best practices regarding both content and format of those test report summaries. While this guide is intended to describe the reporting of results from one standard at a time, the user is encouraged to use its principles when expanding or extending to apply to reports that summarize results from multiple standards.

1.2 This guide does not seek to address test report summaries for other applications outside of medical and surgical devices and materials, and it may not be appropriate for every medical or surgical device or material. The recommendations and principles are intended to be applicable to any medically related standard.

1.3 This guide is intended to help the user in generating test report summaries and to help consensus standards developers to write or revise Report sections of individual standards. It is intended to be applicable to any document other than a materials certificate where the user would be expected to provide a report. This guide is also not applicable to a material specification or a document that only describes general information without specifying any methods or results.

1.4 This guide is intended to supplement but not supersede any instructions provided in the Report section of an individual standard being applied, and if there is a conflict between the two documents, the individual standard shall take precedence. For example, if this guide fails to mention that a particular piece of information should be included in a test report, but the Report section of the standard requires that piece of information, or vice versa, the individual standard's requirements shall be followed.
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 Contact
 Terry O. Woods
  FDA/OC/CDRH/OSPTI/ORR/DSCA
  301-796-2503
  terry.woods@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
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