1.1 This guide is intended as a resource for individuals and organizations involved in the design, manufacture, testing, and regulation of hip replacement systems (HRS). 1.2 In this guide, a standardized method to measure the efficacy, effectiveness, and safety of HRS devices to provide a least burdensome approach to designing, reviewing, and accepting human clinical trial protocols for the U.S. Food and Drug administration (FDA) is proposed. 1.3 This guide is intended to provide consistency in study design, review, and the FDA approval process to speed up introduction of new devices to the health care market. 1.4 This guide is not intended to address the reclassification of HRS devices. 1.5 For the purpose of this guide, an HRS is any device that is intended to replace the hip joint, in part or in total, as a treatment for joint disease, trauma, or dysfunction, where functional restoration and pain relief are the desired outcomes. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Keywordsclinical trial design; hip replacement systems; HRS; HRS devices
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Gregory Brown, MD
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