The new article highlights aspects related to the MDDT program, its intended purpose, and its benefits.
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the qualification of medical device development tools (MDDT). The document provides an overview of the applicable regulatory requirements set forth under the existing legal framework, as well as additional recommendations and clarifications to be considered 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 they 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.
MDDT and Qualification
First of all, the authority explains in detail a concept of a medical device development tool. According to the guidance, an MDDT is a method, material, or measurement used to assess the safety, effectiveness, or performance of a medical device. It is further stated that an MDDT is scientifically substantiated and can be qualified for use in device evaluation to support regulatory decision-making. The document also provides a few examples of medical device development tools, which include, inter alia, non-clinical assessment models (NAMs), biomarker tests (BTs), and clinical outcome assessments (COAs). It is also important to mention that the qualification of medical device development tools by manufacturers takes place on a voluntary basis.
As further explained by the authority, it will make its qualification upon review of the respective Qualification Package. According to the guidance, qualification stands for a voluntary assessment of a medical device development tool addressing its scientific justification. In particular, qualification reflects CDRH’s expectations that, within a specified context of use (a statement that describes the conditions and boundaries within which the MDDT has been qualified for use), the results of an assessment that uses an MDDT can be relied upon in device evaluation and to support regulatory decision-making.
The entire medical device development tool program is initially intended to encourage further development of tools used to streamline the entire medical device development process. The program provides that once an MDDT is qualified for a specific use, it should become available to other medical device manufacturers (which could be licensed) to be further used without the need for additional qualification or assessment. At the same time, the mere existence of a medical device development tool does not make its use mandatory in the course of medical device development or further regulatory submissions. Hence, it does not preclude the use of other relevant tools when necessary. Furthermore, a new tool could be qualified for the same use even if one relevant tool is already qualified.
The principle of public availability of qualified medical device development tools has been introduced in order to facilitate and streamline the overall process of medical device development by all the manufacturers involved. Thus, a tool could be qualified only when necessary information could be publicly disclosed, and in no event would the authority disclose any information related to a tool without the respective permission of its developer.
MDDT Qualification Benefits
The document also outlines the main benefits of MDDT qualification for the industry in general. As it was mentioned before, it is expected to positively impact the general predictability and transparency of the evaluation process for new medical devices, as well as the regulatory decision-making process associated with it. The assessment involving qualified MDDTs will be accepted by the authority in terms of the necessary evidence demonstrating that the medical device in question complies with any and all applicable regulatory requirements it is subject to.
The authority also mentions that the program described herein also contributes to further advances in regulatory science by mitigating the gap between general scientific research and medical device development, and ensuring the proper performance, quality, and safety of medical devices. In such a way, the authority intends to improve the overall regulatory process for medical devices, reducing the time and efforts needed to develop new products and also assessing their safety and effectiveness when making regulatory decisions regarding their marketing and use in the US.
According to the guidance, qualification also facilitates tool development and adoption, including through collaboration in a non-competitive setting, where multiple interested parties (individuals/stakeholders, companies/consortia, or organizations) may work together and pool resources to expedite the development, validation, and use of an MDDT.
As explained by the authority, the use of the program described in the guidance also contributes to the more efficient allocation of review resources. In particular, once a qualified medical device development tool is used, there is no need to assess the tool itself when considering the accuracy and reliability of the data provided to substantiate the claims and demonstrate compliance with the applicable regulatory requirements.
MDDT Use in Device Evaluation
The document also covers aspects related to the use of medical device development tools in product evaluation and respective decision-making processes. As it was mentioned before, they could be used when demonstrating compliance of the product subject to review with the applicable safety and performance requirements under the existing regulatory framework. Apart from this, they could also be used for additional processes, e.g., patient selection or monitoring. According to the guidance, specific roles that medical device development tools could be used for include, inter alia, the following:
- To reduce test duration, minimize sample size, or replace a standardized non-clinical bench performance test, e.g., using a computational model;
- To replace an evaluation typically conducted in human studies with an evaluation done in animal or engineering models;
- To stratify patient population by predicted risk and/or effectiveness outcomes.
In summary, the present FDA guidance provides an overview of the regulatory framework related to medical device development tools. The document highlights the key benefits associated with the respective program and explains how it contributes to the overall regulatory decision-making process.
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