The new article addresses the aspects related to the description of functionality and intended use to be included in the submission in the context of patient-matched guides.

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Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance document dedicated to patient-matched guides to orthopedic implants. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and 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 also mentions 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. Once finalized, the guidance would represent the current position of the authority regarding the matter, but could be subject to changes in the future, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. 

The scope of the guidance covers, inter alia, the information to be included in premarket submissions with respect to patient-matched guides accompanying implantable medical devices intended to be marketed and used in the US.

Pre-operative Planning

In order for the detailed instructions on the use of the device in question for its intended purpose to be developed, the following information should be included in the marketing submission: 

  • Implant planning and alignment methods and goals. The authority expects the applicant to provide a planning process description addressing the implant alignment methods as set forth by the original device manufacturer.
  • A description of the healthcare professional’s involvement in the guide design process, including an identification of the parameters that can be modified, and at which steps the healthcare professional provides input and concurrence. The authority also mentions that in case the latter will have access to images, their quality and resolution should also be addressed. Should the original image quality be altered by the manufacturer, it should be a statement that these specific images are intended exclusively for pre-operative planning, and should not be used for diagnostic purposes. 
  • A description of how requests for plan modifications and the final plan concurrence are processed and documented by the guide manufacturer and the healthcare professional.
  • An example of any surgical proposal(s) or final report(s) that are communicated to the healthcare professional. As further explained by the authority, they should include sufficient information for healthcare professionals to be able to make decisions. 

Guide Design and Patient-Matched Features Definition Description

The document also covers the aspects related to the way the characteristics of the device and its performance should be reflected in the submission. In particular, the authority expects the manufacturer to provide a summary description of the guide design process to illustrate how the generic guide model is modified to yield a patient-matched guide, including the targeted bone/guide interface location. According to the guidance, such a description should describe the way guide features correlate with the recommendations on the way the system should be aligned. 

As further explained by the authority, a party responsible for a medical device should take into consideration the following: 

  • A proper process is to be established in order for patient-specific features to be incorporated into a generic guide model. The said process should address the most important aspects and structures, and also explain the way these structures are positioned. 
  • For each of the applicable parameters, default values should be identified (including the upper and lower limits).

Guide Construction Description

As explained by the authority, when developing the guide construction method, a responsible party should take into consideration the way the quality control will be maintained with respect to dimensional characteristics in the course of the entire manufacturing process. In particular, it is important to identify pre-determined dimensional specifications and tolerances. 

Surgical Technique Description

The information included in the submission should also cover the aspects related to the surgical techniques in order to ensure the safety and proper performance of the device when used for its intended purpose. In particular, the authority expects the responsible party to provide: 

  • A description of how the guide’s recommended surgical technique is compatible with the implantation technique recommended by the implant manufacturer;
  • A description of any methods available for converting to traditional manual implantation techniques (if appropriate) and at which surgical steps this conversion is possible;
  • A description of how the healthcare professional would detect and remedy an incorrect guide alignment or surgical outcome;
  • A description of any additional considerations that may be necessary due to anatomical variation in the indicated patient population (e.g., patient size, bone condition).  

In summary, the present guidance provides an overview of the information to be included in the premarket submissions in terms of patient-matched guides in order to ensure its completeness. The authority outlines the key points to be considered by medical device manufacturers with respect to the intended use of the device and information to be communicated to healthcare professionals using the device in order to ensure its proper performance as well as the safety of patients. 

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