FDA released a draft guidance document for patient matched guides for orthopedic implants.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 achieve manufacture of the implants and fixtures.
SoftwareCPR Partner Windi Hary and I have provided a few notes and key portions of the guidance and have provided our marked up guidance as a job aid to SoftwareCPR website subscribers. Retrieve the marked up guidance here: SoftwareCPR markup of patient-matched-guides-ortho-guidance
Keep in mind that this guidance does not supersede other guidance from FDA regarding software quality, but is meant to focus and draw attention to key software quality assurance aspects for Patient Matched Guides.
Other related SoftwareCPR thoughts on the Final Guidance on Content of Premarket Submissions for Device Software Functions