The FDA has issued new draft guidance that outlines rules for sponsors filing premarket submissions for patient-matched guides used in orthopedic surgeries, according to a June 27 report from Regulatory Focus.
The new guidance details design and performance expectations for new orthopedic devices. The guidance specifically addresses patient-matched guides used in preoperative planning stages for orthopedic implant surgeries.
The FDA will require sponsors to submit certain information with their submissions, including the patient-matched guide's performance and a description of the overall process for using the guide.
The agency will also require information on the steps that ensure a patient's preoperative plan is maintained throughout the guide's design and manufacturing process.
Sponsors are also asked to consider additional factors, including clinical and nonclinical performance testing of the device, labeling, sterility, biocompatibility, use of software and modifications to the device.
Significant changes made — including changes in design, critical guide structure or automating a new segmentation — will warrant submitting a new 510(k) submission.