The document highlights the key points related to the regulatory requirements for certain orthopedic devices based on the draft guidance issued by the authority.
Table of Contents
The Food and Drug Administration (FDA or the Agency), the US regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to orthopedic non-spinal bone plates, screws, and washers placed on the market under 510(k) premarket notification framework. Once finalized, the guidance will provide an overview of the existing regulatory requirements, as well as additional clarifications and recommendations to be considered by the parties involved in order to ensure compliance thereto. At the same time, it is important to mention that 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.
The products covered by the guidance are intended for orthopedic bone fixation, while the ones intended for spinal, mandibular, maxillofacial, cranial, and orbital fracture fixation are falling outside the scope of the present document.
The document also contains references to the FDA-recognized voluntary consensus standards medical device manufacturers may refer to when demonstrating compliance with the applicable regulatory requirements.
Regulatory Background
As it was mentioned before, the scope of the guidance covers non-spinal, non-resorbable bone plates, screws, and washers being the implants intended for bone fixation. According to the existing classification rules, these products are class II medical devices. The purpose of the guidance is to improve the overall consistency in information to be included in submissions related to the said products in the context of applications for marketing approval. In particular, by the virtue of the guidance, the authority intends to address the common deficiencies with respect to the description of products and performance testing conducted. The product codes applicable to the devices covered by the scope of the guidance are HTN, HWC, and HRS. In terms of other aspects related to these products, the authority refers to separate guidance documents covering performance criteria. Recommendations provided in this guidance should also be construed in conjunction with the guidance document dedicated to the format for Traditional and Abbreviated 510(k)s.
Product Overview and Limitation of Applicability
The document further provides additional clarifications regarding the products covered by its scope, including the overview of the materials used to manufacture these devices. According to the document, these materials include, inter alia:
- Titanium alloy,
- Commercially pure titanium,
- Stainless steel,
- Cobalt-chrome alloy,
- Polyetheretherketone,
- Chopped carbon fiber reinforced.
The authority also mentions that recommendations provided in the guidance are non-exhaustive in their nature, nor are supposed to cover all the potential cases. In particular, the guidance does not specifically address:
- Nitinol devices,
- Coated devices,
- Devices with surface modifications,
- Devices incorporating antimicrobial agents,
- Devices with complex geometries,
- Devices with differing modularities,
- Devices with unique geometric features,
- Devices that utilize unconventional surgical techniques,
- Resorbable devices,
- Additively manufactured devices, or
- Devices possessing other unique technological characteristics.
Should any of the above points apply to the device in question, the authority recommends the manufacturer to follow a Pre-Submission pathway in order to obtain its feedback in advance. In this respect, the authority refers to the guidance document dedicated to the Q-Submission Program.
The products falling outside the scope of the present guidance also include:
- Bone plates and screws that are intended for mandibular, maxillofacial, cranial, and orbital fracture fixation;
- Bone plates and screws that are intended for use in the spine and suture anchors and
- Fixation components that are part of a bone anchor tightrope.
Indication for Use
When providing premarket submission recommendations, the authority starts with addressing the aspects related to the indications for use. In particular, the authority mentions that a detailed description of the indications for use should be provided, together with a detailed comparison thereof to the legally marketed device. The FDA also reserves the right to request additional information in case there is a difference with respect to indications for use.
The document further provides examples of indications for use that are applicable to the devices covered by the scope of the present guidance, namely:
- Long bone fracture fixation,
- Small bone fracture fixation,
- Small bone fragment fixation,
- Fracture fixation of specific anatomical locations,
- Arthrodesis of a joint or osteotomy of the small bones,
- As components of specific cerclage systems.
As explained by the authority, the description of indications for use provided in documentation should be as precise, as possible, while any vague or unclear wordings should not be used.
It is also stated that in certain cases the indications for use should also be similar in terms of the specific anatomical location where the device should be used. Sometimes such claims should be supported by additional information demonstrating the actual performance of the device.
If the indications for use refer to a pediatric population, the details of a specific subpopulation should be provided. In this respect, the authority encourages the manufacturer to follow the recommendations provided in the separate guidance document dedicated premarket assessment of pediatric medical devices.
In summary, the present FDA guidance document highlights the key points to be considered in the context of premarket applications for certain medical devices. The document pays special attention to the aspects to be addressed with respect to indications for use.
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