The new article provides an overview of a guidance document issued by the US regulatory authority and highlights the key points to be taken into consideration by interested parties with respect to the existing legal framework. 

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 the qualification of medical device development tools. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance. At the same time, provisions of the guidance 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 relevant legislation and has been agreed upon with the authority in advance. The present document constitutes a revised version of guidance initially issued by the authority earlier in 2017. 

In particular, the document provides additional detail with respect to a voluntary program for the qualification of medical device development tools (MDDTs) for use in evaluating devices subject to regulation by the Center for Devices and Radiological Health (CDRH). The latter expects the approach described in the guidance to facilitate the development of new products, as well as their timely evaluation through the instruction of additional means for collecting information that is reasonably necessary to demonstrate compliance with the applicable regulatory requirements, with this means being more efficient and predictable. The above applies to all the information intended to be used in the course of a regulatory decision-making process related to medical device submissions. 

According to the guidance, its purpose is to describe the framework for the voluntary proposal and qualification of an MDDT, including definitions of applicable terms, criteria for evaluating an MDDT for a specific context of use, considerations for qualifications, and the contents of a qualification package. The document is intended to assist submitters (defined as any party responsible for a medical device to be placed on the market) in following the procedures set forth by the respective legal framework. At the same time, the authority explicitly states that the present document does not discuss the review of MDDTs that are submitted in individual premarket regulation submissions for use with a particular medical device, nor does it address the specific evidentiary or performance expectations for the qualification of an individual MDDT submission.

Terms and Definitions

First of all, the document provides definitions of the most important terms and concepts used in the context of Medical Device Development Tools described in the guidance, including, inter alia, the following ones:

  • Medical Device Development Tool (MDDT) stands for a method, material, or measurement used to assess the safety, effectiveness, or performance of a medical device. The authority further explains that each tool should have a proper scientific justification and be allowed for use to address specific device development needs. 
  • Context of Use (COU) stands for a statement that fully and clearly describes the way the MDDT is to be used and the medical device development-related purpose of the use. 
  • Performance Criteria refer to objective performance measures of the MDDT outlined in the qualification plan that describe how the tool can be considered suitable within the proposed context of use. As explained by the FDA, this includes, for instance, the approach to be applied when assessing the consistency of a tool, its accuracy, or sensitivity. Moreover, the applicable performance criteria should also be followed by the respective acceptance criteria. 
  • Proposal Package refers to the initial MDDT submission, or MDDT Proposal, where the MDDT submitter provides the tool description, regulatory utility (how the tool supports safety, effectiveness, or performance of a medical device in a regulatory submission), qualification plan, and performance criteria to describe the expected performance of the tool. 
  • Qualification Package stands for the documented evidence, following the proposed qualification plan, comparing the actual performance of the proposed MDDR to the performance criteria detailed in the Proposal. 

Qualification stands for a conclusion based on the FDA review of the MDDR Qualification Package. The appropriate decision confirms that the tool in question is reliable enough to be used in the context of the regulatory decision-making process.

MDDT Categories

As explained by the FDA, all Medical Device Development Tools could be divided into three main types based on the way they are intended to measure the respective parameters, namely:

  1. A Non-clinical Assessment Model (NAM) applies to a non-clinical test model or method that measures or predicts parameters of interest with regard to device safety, effectiveness, or device performance. According to the guidance, this could include the use of models in lieu of clinical testing, the use of in vitro models instead of animal testing, as well as any other models. 
  2. A Biomarker Test (BT) stands for a test or instrument used to detect or measure a biomarker. For instance, such tools could be used for patient selection in clinical trials. 
  3. A Clinical Outcome Assessment (COA) is a tool that describes or reflects how a person feels, functions, or survives and can be reported by a health care provider, a patient, a non-clinical observer (such as a parent), or through the performance of an activity or task. The authority also mentions that this tool could be used for collecting the necessary data either in a clinical environment or remotely. It could also be used to measure the effect of the treatment in question. According to the guidance, the COAs themselves could also be divided into four types, one of which is patient-reported outcome measures. 

In summary, the present FDA guidance highlights the key points related to medical device development tools, their regulatory nature, and the approach to be applied. The document also describes the way the tools could be divided into types based on the way they collect the necessary information.

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