FDA Premarket Review of Orthopedic Spinal Devices

Spinal implants are regulated by the Food and Drug Administration (FDA) in the Center for Devices and Radiological Health (CDRH). This chapter focuses on the premarket activities at CDRH that help determine the safety and effectiveness of orthopedic spinal devices prior to reaching the market. The specific topics discussed in this chapter include:

• FDA organizational structure and medical device classification
• The main FDA premarket submission types
• The types of evaluations used to assess the performance of spinal devices prior to reaching the market including mechanical testing, cadaver testing, computational modeling, animal testing, and clinical trials

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FDA Premarket Review of Orthopedic Spinal Devices

Market approval processes for new types of spinal devices: challenges and recommendations for improvement

Mechanical and Biomechanical Testing of Spinal Implants

Notes

All medical devices are subjected to general controls which include, for example, registration and listing, medical device reporting, and good manufacturing practices

Special controls can include activities such as special labeling requirements, demonstration that the device components are biocompatible, or non-clinical performance testing such as mechanical testing or electromagnetic compatibility

Certain types of devices classified into Class III that were in commercial distribution in the United States prior to May 28, 1976 (i.e., preamendment devices), may be cleared through the 510(k) process until the FDA issues an order requiring them to go through the premarket approval process or reclassifying them into Class I or Class II

Information on orthopedic HDE approvals can be found in the searchable HDE database on the FDA website: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/hde.cfm

ISO and ASTM standards mentioned in this chapter are published on an annual basis and are available via the organizations’ websites: www.astm.org and www.iso.org

Coefficient of variation for a given test result is the standard deviation normalized to the mean. This parameter allows for comparisons of variability across tests

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Author information

Authors and Affiliations

1. Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA Katherine Kavlock, Srinidhi Nagaraja & Jonathan Peck

1. Katherine Kavlock