Publications

MD&M 2010 Presentation: FDA Approach to Preclinical Testing

    • Reference:
    • Peck, J. FDA Approach to Preclinical Testing. Presented at the 2010 MD&M Meeting in Minneapolis, MN, October 12, 2010.
    • Keywords:
    • Testing, Materials Selection, FDA Approval
    • Permissions:
    • The PDF of this presentation is made available on www.medicalpeek.org with the permission of the author.

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Abstract

This MD&M Minneapolis presentation by Jonathan Peck discusses the role of non-clinical testing in the medical device clearance/approval process at FDA. More specifically, the talk will attempt to cover some of the general pros and cons of bench testing, animal testing, and modeling (FEA). Relevant to PEEK, the topic of material selection and the 522 order on motion preserving spine implants are covered in the talk.

ABOUT THE SPEAKER

Jonathan H. Peck, Scientific Reviewer, FDA

Jonathan Peck has a B.S. and Masters from Cornell University in Mechanical Engineering (concentration Biomechanics). Jonathan has been working for the FDA from 2003 to present doing premarket reviews in the Orthopedic Devices Branch.