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Recently published FDA draft guidance provides device manufacturers with recommendations on supporting premarket submissions for patient-matched guides to orthopedic implants.
Patient-matched guides are designed to implement the pre-operative plan created by the orthopedic surgeon. Guides are expected to continue to play an important role in orthopedic procedures as more surgeons adopt enabling technology and digital tools. The guidance document provides clarity and transparency regarding the information that should be included in regulatory submissions, and what orthopedic manufacturers should consider when designing these types of devices. Its recommendations are intended to increase the efficiency and consistency of the regulatory review process.
Here are highlights of FDA’s recommendations taken from the complete draft guidance.
Indications for use. Regulatory submissions should include the surgical approach and the procedure in which the patient-matched guide will be used. Submissions should also include implant systems that the guide will support, the intended patient population, the types of imaging modalities (such as MRI and CT scans) needed to design the guides and the anatomic landmarks necessary for preoperative planning.Â
Device description. FDA highlighted the importance of establishing design templates and pre-specified design parameters during the production of patient-matched guides.
Device descriptions should include details about the design process, a comprehensive list of guide components and available sizes, the preoperative software used to produce the guides and the healthcare professional’s role in the process and which parameters they can modify. Manufacturers should also show how quality control is maintained during the production process.
Software testing. Performance testing of the software used to develop preoperative plans and the designs of patient-matched guides must provide assurance that the programs operate as intended. Test data must also show that the software provides accurate and reproducible results for compatible implant systems.
Biocompatibility. The biocompatibility of all patient-contacting materials in devices must be determined. Manufacturers can reference previous testing for devices that are identical in composition and processing methods to guides with a history of successful use.
When such a device is not available, manufacturers should note identified biocompatibility risks and the steps taken to mitigate those risks.
FDA suggests referring to International Standard ISO 10993-1 to identify the types of biocompatibility testing and assessments that should be considered and recommendations for conducting related tests.
Sterility. Patient-matched guides labeled as sterile should include a detailed description of the sterilization process, including the packaging, sterilization site, radiation dose when radiation sterilization is used and maximum levels of chemical sterilant residuals that remain on the device when chemical sterilization is employed — and an explanation as to why those level are acceptable for the device type and expected duration of patient contact.
Manufacturers should also provide a description of the method used to validate the sterilization cycle and sterilization validation data, the relevant consensus standards used to guide the sterilization process and aspects of the standards that were not met. If there is no consensus standard, manufacturers must provide a detailed description of the sterilization process and validation protocol.
Submissions for non-sterile patient-specific guides should include reprocessing instructions based on FDA guidance for reprocessing medical devices in the healthcare setting.
Shelf life and packaging. The shelf life of non-sterile guides should be an appropriate duration between the capture of preoperative images used to design the guides and their use in surgery so that the performance of the devices will not be impacted. The maximum time allowed between the preoperative images and the planned surgery should be specified.
Guides that are packaged sterile should undergo shelf-life testing to determine the package integrity for maintaining device sterility and functionality in relation to the proposed expiration date. A description of the packaging should include how it will maintain a guide’s sterility, the protocols used to test the packaging’s integrity and the results of the testing.
Shelf-life and package integrity claims for sterile guides should be validated and supported by a package validation study that includes simulated distribution, seal strength testing and an accelerated or real-time aging process.
Non-clinical performance testing. The content and format of non-clinical bench performance testing includes factors related to intra- and inter-designer variability, post-processing mechanical integrity, debris generation and implant alignment accuracy and guide usability. Details related to these factors are included in FDA’s final guidance on non-clinical performance testing.
Clinical performance testing. Although clinical performance testing is not always required for the regulatory evaluation of patient-matched guides, FDA might request the testing in certain circumstances: the indications for use are different from similar legally marketed devices; the device has significantly unique technological characteristics; engineering or cadaver testing reveal issues that need to be evaluated with clinical evidence; labeling claims note improved patient outcomes or reduced surgical times or the surgical approach; and implant alignment specifications and indications for use are different than what’s recommended by the implant manufacturer.
Real-world data (RWD) can be used in some cases instead of traditional clinical data to demonstrate the intended performance of patient-matched guides. FDA provides guidance on the appropriate use of RWD to support regulatory decision-making.
Labeling. Packaging labels must include information intended for healthcare professionals that notes: the implant systems for which the guides were designed; ways to assess proper guide alignment; how to convert to a traditional implantation technique if the patient-matched guides cannot be used; and identifiers of the individual patients for whom guides are created.
Comments on the draft guidance must be submitted to FDA online or in writing by August 28 and should include the docket number FDA-2023-D-2370.
