The article provides a brief overview of the applicable regulatory requirements for orthopedic fracture fixation plates.
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the orthopedic fracture fixation plates. The document describes in detail the applicable performance criteria for the Safety and Performance Based Pathway as set forth by the existing legislation. The guidance is intended to provide additional clarifications and recommendations to be followed by medical device manufacturers and other parties involved. However, the recommendations provided in the guidance are non-binding, and an alternative approach could be applied, provided such an approach is in line with the current regulatory framework. The authority also mentions that the present guidance is subject to implementation without prior public consultations, and is based on the less burdensome approach.
As it was mentioned before, the guidance describes the approach to be applied in the context of the Safety and Performance Based Pathway. As explained by the FDA, under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for Orthopedic Fracture Fixation Plates will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device. The document also contains references to the FDA-recognized voluntary consensus standards medical device manufacturers may refer to when demonstrating compliance with the applicable requirements.
Initially, the Safety and Performance Based Pathway is intended to facilitate the regulatory procedures for well-understood types of medical devices provided the manufacturer can demonstrate that the device in question is as safe and effective as a similar product already placed on the market. In such a case, it is important to determine the proper performance-based criteria to be used, as well as the applicable testing methods. Such a determination should be based on the information available, and the experience of FDA staff. At the same time, FDA recognizes that in some cases, it may be more burdensome for a submitter to conduct testing against an appropriate predicate device to demonstrate equivalence for the necessary set of performance and technical characteristics than to demonstrate their device meets appropriate performance criteria established by FDA. Thus, the authority believes that the approach described in the document is the one that imposes a reasonable burden on medical device manufacturers and is well-balanced in terms of public health protection.
Scope: Medical Devices Covered
The scope of the present guidance covers the regulatory aspects related to Class II non-spinal fracture fixation plates regulated under 21 CFR 888.3030 (product code HRS). At the same time, the criteria described in the documents also correspond to the requirements for medical devices covered by the product code HWC and regulated under 21 CFR 888.3040. In this regard, the authority refers to the guidance document dedicated to the Orthopedic Non-Spinal Metallic Bone Screws and Washers. The devices covered by the scope of the guidance are intended for ensuring proper fixation of opposing bone fragments in case of fractions. The authority also outlines the types of medical devices that are falling outside the scope of the guidance which includes, inter alia, fracture fixation plates for orbital fracture fixation. Apart from this, in the case of products intended for new fracture types, the manufacturer would have to demonstrate substantial equivalence. For such products, the authority encourages the manufacturers to file a Pre-Submission to commence the discussion.
The characteristics of the devices covered by the scope of the guidance depend on the anatomical locations in which these devices are intended to be used. According to the guidance, premarket submissions should describe the anatomical use location of each plate and identify the screws that are compatible with each plate. In particular, it is necessary to provide a detailed comparison to the similar medical device already placed on the market. The submission should contain a detailed description of both plate and screw characteristics including the geometrical dimensions and physical properties. The description should be accompanied by detailed drawings highlighting all the important aspects necessary for the authority to establish equivalence to the medical device already approved for marketing and use in the country.
At the same time, implants with certain specific features are falling outside the scope of the guidance. Such products include, inter alia, the following ones:
- Combination products;
- Resorbable devices;
- Additively manufactured devices;
- Devices with coatings;
- Devices that utilize surgical techniques or associated instruments outside the standard of care.
The authority also reserves the right to request additional information and details, should it be reasonably necessary to assess the safety- and performance-related matters associated with the device subject to review. Furthermore, should the manufacturer decide that additional testing is required, this should be discussed with the authority as well.
Testing Performance Criteria
According to the guidance, in case the product in question is eligible for the review under the Safety and Performance Based Pathway, and the manufacturer will decide to follow this approach, the authority will not require a direct comparison to a similar device to be provided by the manufacturer. Instead, FDA recommends that [the applicant] provides a results summary for all tests evaluated in addition to the other submission information (e.g., Declaration of Conformity (DoC)) recommended for each test or evaluation. At the same time, the authority reserves the right to request additional data demonstrating compliance with the applicable regulatory requirements and performance criteria. Initially, the 510(k) framework provides that results summary, test protocols, and complete test reports should be submitted by the manufacturer applying for marketing approval.
In summary, the present FDA guidance outlines the basics of the regulatory approach to be applied concerning orthopedic fracture fixation plates in the context of the Safety and Performance Based Pathway. The document describes in detail the performance criteria to be applied when evaluating the safety- and performance-related aspects. The document provides additional clarifications regarding the most important matters to be addressed in submission and also provides a list of applicable standards medical device manufacturers may refer to when demonstrating compliance with the products in question.
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