Understanding the FDA’s Custom, Compassionate Use, and HDE Pathways

William M. Mihalko, MD, PhD

Customization is a fact of life. As consumers, we insist on customizing many of the products we purchase. As learners, we want a program geared to our individual needs. Even in medicine, patients expect a personalized treatment program that addresses their specific needs.

As orthopaedic surgeons, we often find ourselves in situations that are best addressed by a customized device or implant, particularly if we have a practice focused on reconstructive surgery (including spine, arthroplasty, oncology, and pediatrics). It may be that the patient’s anatomy is such that only a truly custom device is appropriate. Or, it may be that the patient has comorbid conditions that prevent him or her from participating in the clinical trial of a device that would otherwise be suitable.

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