FDA drafts guidance to aid orthopedic implant guide makers

The US Food and Drug Administration (FDA) has issued draft guidance that outlines its expectations from sponsors filing premarket submissions for patient-matched guides used in orthopedic surgeries, detailing design and performance expectations for the devices.

The draft guidance specifically addresses patient-matched guides that are used in the pre-operative planning stage of orthopedic implant surgeries. The surgical plans themselves are based on landmarks on pre-operative patient images and take into consideration the implant system being used in the surgery.

“As the designs of the patient-matched guides differ slightly between each patient, it is important to establish a design template and a range of pre-specified allowable design parameters to ensure a consistent and accurate guide,” said FDA in their guidance. “In addition to the design process, the preparation (cleaning/sterilization) and actual surgical use of the guide (surgical technique) are also critical to patient-matched guide performance.”

FDA says sponsors should include certain information in their submission to characterize the patient-matched guide and its performance, such as a description of the overall process for using the guide. This may include a flowchart detailing who will be involved in the surgery, and the steps used to design and develop the guides. The agency also wants information on the steps to ensure that the patient’s pre-operative plan is maintained throughout the guide’s design and manufacturing process, any qualification and training needed to use the guide, and information that ensures that compatibility of the guide will be monitored and maintained for the indicated implant.

While the guidance is meant to help sponsors design their guides, FDA notes it is not meant to address all quality system considerations or regulatory requirements for patient-matched guide designs. Manufacturers of class II and class III devices that fall withing the scope of the guidance are expected to establish and maintain procedures to control the design of the guide to ensure that specified design requirements are met.

“Manufacturers must also establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met,” FDA added. “Where the results of a process cannot be fully verified by subsequent inspection and testing, the process must be validated with a high degree of assurance and approved according to established procedures.”

Sponsors are also asked to consider factors such as clinical and nonclinical performance testing of their device, labeling, sterility, biocompatibility, use of software, and modifications to their device. The agency notes that significant changes to the device may warrant submitting a new 510(k) submission, such as a change in the design of the patient contacting regions, guiding slots/holes, or critical guide structure; modification in the planning process such as automating a manual segmentation step; patient imaging modality or anatomic contact location.

However, other changes such as a software update to off-the-shelf segmentation software, format of the pre-operative planning report, and non-patient contacting and non-critical guide structure would not likely necessitate a new 510(k).

When designing a guide, FDA also says it's important for sponsors to consider any conflicts that may arise from the orthopedic patient-matched guide’s indications for use and the implant system’s cleared or approved indications or contraindications, as conflicts could cause the device to be misbranded.

Stakeholders can comment on the guidance on www.regulations.gov under docket number FDA-2023-D-2370 until 28 August 2023.

Draft guidance

FDA drafts guidance to aid orthopedic implant guide makers

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