Who Sets the Standards?

It’s time for surgeons to become involved

William M. Mihalko, MD, PhD

All medical devices used by orthopaedic surgeons are subject to approval processes that involve testing of these products, using standards that are developed and approved by the International Standards Organization (ISO) and/or the American Society for Testing Materials International (ASTM International). These standards are typically developed by a team of academic and corporate engineers, along with representatives from the U.S. Food and Drug Administration (FDA), who participate in an unofficial manner.

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