FDA released a draft guidance document for patient matched guides for orthopedic implants. The guidance provides recommendations to manufacturers regarding the design-and-production process for these types of devices. Patient matched guides, as the name implies, are unique to the patient and are created to assist pre-surgical planning. The clinician is better able to visualize proper design of the implant and plan surgical actions to enhance intended use. Most often, the overall planning process involves acquisition of patient specific images, design of implants and surgical fixtures tailored to the patient images, and streamlined production processes to . . .
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