FDA Guidance on Certain Orthopaedic Devices: Product Description

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 510(k) premarket notification pathway. In particular, the document outlines the key points to be considered by medical device manufacturers and other parties involved when preparing the respective submissions. 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, but rather to provide additional clarifications regarding the existing regulatory requirements, as well as recommendations to be followed in order to ensure compliance thereto. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the underlying legislation and has been agreed with the authority in advance. 

Once finalized, the document will represent the current thinking of the authority on the matter. FDA also reserves the right to introduce changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the applicable regulations. 

The document describes, inter alia, the key aspects to be reflected in the submission in order to ensure that the authority will have all the information necessary to review the application for marketing approval.

Device Description: Key Points 

First of all, the authority mentions that the device in question should be identified by the respective regulation number, as well as the product code. In the case of bone plates and screws, applicants are also encouraged to provide images of the products subject to review. 

General information about the device could be provided in a form of a table covering the following aspects:

• Intended use,
• Product code,
• Target population,
• Anatomical site(s) of use,
• Provided sterile/non-sterile,
• Sterilization method,
• Shelf life,
• Packaging (if provided sterile),
• System components that can be reprocessed and, if so, are cleaning instructions included and location within the submission,
• Summary of how the device achieves its intended function. 

Furthermore, the authority also mentions that the submission should include a table with the name of each component in the system with its associated part number, while descriptive information for each component should include critical dimensions for the entire range of available sizes in tabular format. In order to assist the applicants with following the approach described herein, the authority also provides a few examples demonstrating the way the information could be structured. It is also important to mention that in case references to FDA-recognized standards are provided, the specific edition of the standard should be indicated. 

Plate Description 

According to the guidance, a section dedicated to the plate description should cover, inter alia, the following:

• Representative image or photograph of component,
• Anatomical site of use,
• Materials,
• Any standards to which the materials conform,
• General plate shape,
• Number of holes,
• Hole dimensions,
• Locking mechanisms, if applicable,
• Screw angle placement ability relative to plate,
• Plate width range (minimum and maximum in the structurally critical region),
• Plate length range,
• Plate thickness range,
• Previously cleared compatible screws,
• New proposed compatible screw sizes,

Washer Descriptive Information 

The document also outlines the scope of information to be provided with respect to washers/bolts. According to the guidance, the details provided by the manufacturer should include:

• Representative image or photograph of component,
• Materials, 
• Any standards to which the materials conform,
• Inner diameter range,
• Outer diameter range,
• Thickness range,
• Previously cleared compatible screws,
• New proposed compatible screws. 

The authority also expects the applicant to provide engineering drawings for each size and part number, as well as the indications of critical dimensions and tolerances. The applicant may also provide a drawing covering all the products, accompanied by a table reflecting the details for each part number. The details to be provided by the applicant include:

• For plates: plate angulation (if applicable), minimum and maximum length, minimum and maximum width in the structurally critical region, minimum and maximum thickness in structurally critical region, screw hole diameter, and distance between screw holes;
• For screws: minimum and maximum length, threaded diameter, core diameter, axial thread length, thread pitch, screw head diameter, height, and thread feature if applicable.  

The document further describes the requirements to be considered in specific cases, depending on the nature of the device in question and, especially, its composition and components used. For instance, in case the device contains fibers, additional information about the latter should be provided, including the length and direction. 

Should the product subject to review be accompanied by surgical instrumentation, information about such instruments should also be provided. The authority mentions that most surgical instruments used in the context of orthopedic bone plates are class I medical devices and, consequently, are exempted from review under the 510(k) framework. The information the authority expects to be provided with respect to bone screws includes:

• Name of the instrument and part number,
• 510(k) number if instrument has been previously cleared,
• Representative engineering drawing(s), schematic, illustration, photograph and/or figure,
• Purpose and brief description of the instrument, 
• Statement clarifying if the instrument is single-use or reusable, 
• Provided sterile/non-sterile,
• Sterilization method,
• Materials,
• Any standards or material specifications to which the material conforms,
• Duration of contact with the patient,
• Color additives, if included in patient contacting components. 

In summary, the present FDA guidance provides additional clarifications regarding the device description to be provided by the applicants with respect to certain orthopedic devices subject to review under the 510(k) premarket notification framework. The document contains device-specific recommendations to be taken into consideration in order to ensure the information submitted is comprehensive and covers all the main aspects. 

Sources:

https://www.fda.gov/media/166507/download 

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