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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 054 Date of Entry 07/06/2020 
FR Recognition Number 11-369
Standard
ASTM  F3292-19
Standard Practice for Inspection of Spinal Implants Undergoing Testing
Scope/Abstract
1.1 This practice provides guidance for non-destructive photographic analysis of spinal implants prior to, during, and after testing. The purpose of this practice is to provide methods for documenting notable changes in implant characteristics (e.g., surface defects, cracks, plastic deformation) that have occurred during the course of a mechanical test. Documenting these changes may assist in understanding if mechanical failure has occurred, and how.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§888.3050 Appliance, Fixation, Spinal Interlaminal Class 2 KWP
§888.3060 Appliance, Fixation, Spinal Intervertebral Body Class 2 KWQ
§888.3060 Spinal Vertebral Body Replacement Device Class 2 MQP
§888.3070 Orthosis, Spondylolisthesis Spinal Fixation Class 2 MNH
§888.3070 Orthosis, Spinal Pedicle Fixation Class 2 MNI
§888.3070 Thoracolumbosacral Pedicle Screw System Class 2 NKB
§888.3075 Posterior Cervical Screw System Class 2 NKG
§888.3080 Intervertebral Fusion Device With Bone Graft, Lumbar Class 2 MAX
§888.3080 Intervertebral Fusion Device With Bone Graft, Cervical Class 2 ODP
§888.3080 Intervertebral Fusion Device With Integrated Fixation, Lumbar Class 2 OVD
§888.3080 Intervertebral Fusion Device With Integrated Fixation, Cervical Class 2 OVE
N/A Prosthesis, Intervertebral Disc Class 3 MJO
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Spinal System 510(k)s, Issued May 2004.

Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, Issued June 2007.

Guidance for Industry and/or FDA Reviewers/Staff: Guidance Document for the Preparation of IDEs for Spinal Systems, Issued January 2000.

Guidance for Industry and FDA Staff: Preparation and Review of Investigational Device Exemption Applications (IEs) for Total Artificial Discs, Issued April 2008.


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
 Jonathan Peck
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIB/
  301-796-5650
  jonathan.peck@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Orthopedic
*These are provided as examples and others may be applicable.
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