The FDA has provided prescriptive guidance to guide sponsors in delivering tailored indications for use for patient-specific guides. A sponsor’s proposed indications for use should include several features, including but not limited to: patient population and imaging modality for guide design.
Taylor Gold West, MBA, RAC
Objectives
- The new draft guidance indicates there are very specific details that should be included in a future 510(k) submission in order to be successful. These include: device description, indications for use and performance testing, at a minimum.
- Ensure your best regulatory submission and boost your chances of success by engaging consultants at RQMIS today to help with your orthopedic patient-matched guide
Patient-Matched Guides
Are you an orthopedic device manufacturer looking to create carefully curated patient-matched guides? Patient-matched guides help ensure patients have improved access to pre-operative planning of their procedures. FDA just released a new draft guidance to help guide manufacturers in understanding what your FDA review team will be expecting for your device submission.
FDA’s new draft guidance on “Patient-Matched Guides for Orthopedic Implants” is a great resource to ensure a successful future submission to the Agency. The guidance covers several important aspects of your future 510(k) submission, such as:
Indications for Use
Device Description
The specific details in your device description and principles of operation will better guide your review team to a conclusion of substantial equivalence. Critical to your submission package are details related to compatibility with implants and accessories, understanding pre-operative planning, patient image acquisition, image quality control, guide design and construction as well as surgical technique.
Software
Proprietary and/or off-the-shelf software may be used to support planning and design of your patient-specific guide. A full description of your software (as expected across all 510(k) submissions) should be provided.
Biocompatibility
Biocompatibility testing on your device material will be needed to demonstrate that the guide(s) does not have an unintended biological impact. Alternatively, a Letter of Authorization may be used if the device material has been previously cleared with identical composition and manufacturing processes.
Sterility
Consistent with other device submissions, devices provided sterile or end-user sterilized devices will have the same expectations for demonstrating sterility as patient-matched guides will come in contact with blood and bone.
Shelf Life and Packaging
Consistent with other device submissions, the manufacturer needs to ensure that device shelf life and packaging are appropriate for the device type and maintaining sterility for the end user (if applicable).
Performance Testing
Additional testing will be needed to support a substantial equivalence argument, including special considerations for the device type (i.e. patient-matched guide). RQMIS has experts in performance testing for orthopedic device types to help guide you to the appropriate type of testing for this niche device area.
Labeling
As described in the device description, the Agency will expect specific details in your device labeling that are specific to patient-matched guides.
Device Modifications
Careful consideration should be given to any device modifications that are made to your original, cleared device submission. Work with us today to help support you in navigating the complex decision tree for this niche device area.
Don't miss a detail.
Our experienced regulatory team can help make the draft FDA guidance work for you.