The new article provides an overview of the guidance document describing the approach to be applied with respect to information the authority expects to be included in submissions for a specific type of product.
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance document dedicated to patient-matched guides to orthopedic implants. Once finalized, the guidance will provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legislation and has been agreed with the authority in advance.
As the authority states, the present document is intended to provide additional recommendations regarding information to be covered by regulatory submissions related to patient-matched guides to orthopedic implants. Apart from this, the document also provides recommendations to be considered by medical device manufacturers with respect to the design process employed. According to the guidance, patient-matched guides are intended to assist in the execution of a pre-surgical plan concurred upon by the patient’s healthcare professional to position an orthopedic implant in a way consistent with the implant’s indicated use. At the same time, the authority additionally emphasizes that even though the document highlights certain aspects related to the design, manufacturers should not rely on it entirely in this respect when ensuring compliance with the applicable requirements set forth under the quality system regulation (21 CFR 820). Furthermore, it is also stated that for class II and class III devices such as identified in the scope of this guidance, manufacturers must establish and maintain procedures to control the design of the device to ensure that specified design requirements are met per 21 CFR 820.30, Design controls. Medical device manufacturers are also responsible for developing and implementing procedures for monitoring and control of process parameters when it takes to validate processes. In all the cases when the result of a certain process cannot be fully verified, the process itself should be subject to validation. Thus, it is stated that FDA interprets these regulations to require manufacturers to establish procedures, including process validation of patient-matched guides to ensure that the device can perform as intended.
The document also references the FDA-recognised voluntary consensus standards medical device manufacturers may refer to when demonstrating compliance with the applicable regulatory requirements.
Patient-Matched Guides: Key Points
As explained by the authority, patient-matched guides are initially intended to implement the pre-operative plan, which is based on the properly defined landmarks and is in line with the intended use of the implant system in question.
The authority further mentions that since the designs of patient-matched guides are slightly different due to the specific needs of each patient, a unified approach is needed, including the design template and also a range of design parameters that will ensure consistency. According to the guidance, the design process includes the following:
- Patient image acquisition,
- Image quality control, segmentation, and anatomical definitions,
- Pre-operative planning and healthcare provider concurrence,
- Guide design and patient-matched features definition, and
- Guide construction.
Apart from the abovementioned aspects, when preparing a patient-matched guide, the manufacturer should also consider the matters related to the cleaning/sterilization of a medical device in question, as well as the surgical use.
The scope of the present guidance covers only the matters related to patient-matched guides for orthopedic implant systems allowed for marketing and use in the US. The document’s main purpose is to provide additional clarity regarding the authority’s expectations in terms of the details to be included in the marketing submission. If followed, these recommendations are expected to facilitate and streamline the review process by improving the overall quality of submissions. Apart from that, the document also outlines the best practices related to the matter.
The document further provides detailed recommendations regarding the design of patient-matched guides and the submission itself.
Indications for Use
In accordance with the applicable legislation, namely, 21 CFR 814.20(b)(3)(i), the term “indications for use” stands for the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended. As explained by the authority, the indications for use should be considered when identifying the technical performance testing parameters to be applied. This includes, inter alia, considering the aspects related to the surgical technique recommended for the implant system in question. In this respect, the authority additionally emphasizes the importance of identifying any potential discrepancies between the intended use reflected in the indications/contraindications of the device itself and also the ones reflected in the corresponding patient-matched guide. According to the guidance, the indications for the use for this type of medical device should include the following:
- The surgical approach and the procedure supported,
- The specific implant system(s) that the guide is intended to support,
- The patient population for which the guide is indicated and whether this is a subset of the implant system’s indicated patient population,
- The types of imaging modalities necessary for designing the guides, and
- The anatomic landmarks necessary for pre-operative planning, at a minimum, should be clearly identified on the patient’s pre-operative radiographic images.
In summary, the present FDA guidance provides an overview of the regulatory requirements for patient-matched guides. The authority outlines the aspects to be covered in the respective submission. It highlights the key points to be considered by medical device manufacturers to facilitate the review process and make it more efficient.
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