The new article addresses matters related to clinical performance testing, labeling, and modifications. For each of the aspects, the document provides additional clarifications, highlighting the key points to be taken into consideration in order to ensure compliance with the relevant regulatory requirements the products described in the guidance are subject to.

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Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance document dedicated to patient-matched guides to orthopedic implants. Once finalized, the document will provide 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. At the same time, the provisions of the document are non-binding in their legal nature and are not 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 upon with the authority in advance.

Clinical Performance Testing: Key Points

The scope of the guidance covers, inter alia,  aspects related to clinical performance testing. As explained by the authority, even though it is not always required, it could be needed in specific cases where the underlying matters cannot be addressed in any other way. For instance, it could be required in the following cases:

  • Indications for use dissimilar from legally marketed devices of the same type;
  • Significantly different technological characteristics;
  • Cases where engineering and/or cadaveric testing raise issues that warrant further evaluation with clinical evidence;
  • Labeling claims about improved patient outcomes or reduced surgical time; and/or
  • A surgical approach, implant alignment specifications, or indications for use other than those recommended by the implant manufacturer. 

As further explained in the guidance, when determining the necessity of clinical testing, the authority will consider alternatives available. Should it be determined that the clinical assessment is required, it could be carried out within the Investigational Device Exemption (IDE) framework. Furthermore, the authority considers the patient-matched guides described in the document to be significant risk devices. In terms of a risk-based approach, the document further refers to the guidance document dedicated to significant and nonsignificant risk medical device studies. Apart from the aforementioned requirements, the parties responsible for clinical investigations should also ensure compliance with the requirements related to institutional review boards and informed consent. 

The FDA also mentions that sometimes “real-world data” (RWD) could be provided instead of the one collected in a traditional way. The necessity for RWD should be determined on a case-by-case basis – for instance, should the product in question be used in the course of health care provision, an IDE most probably would not be required. The authority also refers to the document dedicated to the use of real-world evidence to support regulatory decision-making for medical devices for further guidance.


The scope of the guidance also covers aspects related to labeling requirements that patient-matched guides should comply with. First of all, the authority mentions that these products are exempt from having detailed directions for use since they are prescription devices. At the same time, the labeling should still contain detailed enough information that potential users would reasonably need in order to ensure the device is used in a safe and efficient manner, such as indications for use, methods and duration of administration, as well as hazards and contraindications. 

Moreover, there are certain aspects that are unique to patient-matched guides and should be addressed, namely: 

  • Information regarding the implant systems for which the device has been designed and tested to be compatible;
  • Instructions regarding how the user should assess proper guide alignment;
  • Instructions regarding conversion to a traditional implantation technique if the user is unable or unwilling to use the patient-matched guides;
  • Instructions to irrigate the region during situations where polymeric debris is being generated;
  • Graphic illustrations of key steps that may otherwise be unclear; and
  • A description of the convention used to ensure that the user can map the pre-operative plan to the final guide. 

Apart from the above, it is also important to outline the means of identifying the specific patient for whom the product has been created in order to prevent potential application to the wrong patient.


Another important aspect addressed in the guidance relates to modifications. As set forth under the applicable legislation, a device change or modification that could significantly affect the safety or effectiveness of the device or represents a major change or modification to the intended use of the device requires a new 510(k). The document further provides several examples of changes that will probably require a new submission. The authority additionally emphasizes that the below list is not exhaustive and is provided to illustrate the general approach to be applied, while the final determination should be made on a case-by-case basis. 

According to the guidance, modifications that require a new 510(k) include, inter alia, those related to:

  • Design of the patient’s contact regions, guiding slots/holes, or critical guide structure.
  • Planning process – automate a manual segmentation step. 
  • Patient imaging modality. 
  • Anatomic contact location.

At the same time, a new submission would not be required in the case of:

  • Software update to off-the-shelf segmentation software.
  • Format of the Pre-operative Planning Report.
  • Non-patient contact and non-critical guide structure. 

In summary, the present FDA guidance highlights certain specific aspects to be taken into consideration by medical device manufacturers with respect to patient-matched guides. The document describes the approach to be applied in order to ensure the labeling contains all the information necessary to ensure the device is used in a safe and efficient way.

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