The article describes in detail the aspects related to the way in which comparison to a similar medical device already placed on the market is to be provided, and also on the labeling requirements to be fulfilled to ensure all the important information related to the device is communicated properly to its potential users.
Table of Contents
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 orthopedic non-spinal bone plates, screws, and washers in the context of marketing submissions under 510(k) premarket notification framework. The document provides additional clarifications regarding the existing 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, but rather to assist in achieving and sustaining compliance with the applicable requirements. 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 scope of the guidance covers, inter alia, the aspects related to predicate comparison.
Predicate Comparison: Key Points
Under the general rule, when applying for marketing approval under the 510(k) premarket notification framework, an applicant has to demonstrate compliance with any and all applicable regulatory requirements by the virtue of establishing substantial equivalence to a similar medical device already placed on the market (predicate). For this purpose, an appropriate comparison should be provided, highlighting the differences and similarities between both devices. The authority encourages medical device manufacturers to provide side-by-side comparisons whenever possible and also provides a few tables demonstrating the way the said approach could be applied. At the same time, the authority additionally emphasizes that these tables are provided as examples and should not be considered exhaustive. Moreover, it is stated that the predicate device comparison section of [the] submission should also include a discussion of why any differences in technological characteristics identified in the table(s) do not raise different safety and effectiveness questions, and how the subject device is substantially equivalent to the predicate(s).
General Descriptive Information
According to the guidance, the general descriptive information to be covered by the scope of comparison should include, inter alia, the following aspects:
- Intended use,
- Classification/Product code,
- Target population,
- Anatomical site of use,
- Provided sterile/non-sterile,
- Sterilization method,
- Shelf life,
Apart from the general information about the medical devices in question, depending on the type of the product subject to review, the comparison should also cover:
- Plate descriptive information,
- Stand-alone screw descriptive information,
- Washer descriptive information.
With respect to the information to be provided, the authority emphasizes the importance of the following aspects:
- The mechanical performance of bone plates and screws depends significantly on the materials used. Hence, should the materials used for the device subject to review be different from the ones used for the predicate, or different manufacturing methods or processing steps are applied, the authority reserves the right to request additional information or evaluation to be conducted. In such cases, medical device manufacturers are encouraged to get in touch with the authority in advance in line with Pre-Submission and Q-Submission pathways.
- Medical device manufacturers should also pay attention to galvanic corrosion that could potentially take place when there are metallic fracture fixation hardware components being in touch with components made of dissimilar metals. Furthermore, should novel materials be used, the matters related to corrosion should be subject to special assessment. Should the materials used be different from the ones used in a predicate device, the difference should be assessed in terms of risks associated with the new materials used.
Another important aspect addressed in the guidance relates to the labeling to be used for medical devices. Under the general rule, an example of labeling should be included in the application to be assessed by the authority in terms of compliance with the applicable regulatory requirements. According to the document, the labeling and labels used should provide a detailed enough description of the device in question, its intended use, as well as the directions for use.
In this respect, it is important to mention that since bone plates, screws, and washers are prescription devices, they are falling within the scope of the appropriate exemption from the requirement to have adequate directions for use, provided the respective regulatory requirements are met. In particular, the information suggested labeling contains should be sufficient for a healthcare professional to use a medical device in a safe and effective way for its intended purpose.
As further explained by the FDA, the labeling used for the devices described in the present guidance should include, inter alia, the following information:
- Device description (including material and sterility status);
- Device use (including single-use/reusable, intended users or specific patient populations);
- Contraindications (e.g., active infection, inability to comply with post-operative weight-bearing instructions, inadequate bone stock, or poor blood supply);
- Warnings (e.g., not to use the device across an active growth plate for devices indicated for pediatric use);
- MR safety information;
- Cleaning and sterilization instructions, if applicable; and
- Removal instructions (particularly for devices indicated for pediatric use).
In summary, the present guidance highlights specific aspects to be addressed in applications for marketing approval for certain orthopedic devices intended to be marketed and used in the US. The document pays special attention to the existing requirements for labeling and the information it should contain.
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