The Journal of Bone and Joint Surgery (American). 2009;91:17-21.
doi:10.2106/JBJS.H.01337
© 2009 The Journal of Bone and Joint Surgery, Inc.
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The Challenges of Clinical Validation of Emerging Technologies: Computer-Assisted Devices for Surgery

Michel Janda, MS1 and Barbara Buch, MD1

1 Division of General Restorative and Neurological Devices, Center for Devices and Radiologic Health, U.S. Food and Drug Administration, 9200 Corporate Boulevard, HFZ-410, Rockville, MD 20850

Disclosure: The authors did not receive any outside funding or grants in support of their research for or preparation of this work. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.

Disclaimer: No official support or endorsement of this article by the U.S. Food and Drug Administration (FDA) is intended or should be inferred. The views presented in this article do not necessarily reflect those of the FDA. The findings and conclusions in this article should not be construed to represent any FDA determination, guidance, or policy.

Over the last decade, the use of computers and robotics in medicine has increased commensurate with emergent advances in technology. This article largely focuses on the challenges that the U.S. Food and Drug Administration faces when evaluating new technologies for entry into the market. How different categories of devices are categorized and what types of data have been used for regulatory approval or clearance are described. These are compared with expectations that the clinical community may have for these devices. A brief discussion of current regulatory thinking about these types of devices is also included.


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