The new article describes in detail the aspects related to the regulatory status of medical device development tools in comparison to medical devices.

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 program described in the guidance is intended to facilitate the development of new medical devices by reducing the regulatory burden and also to ensure a more efficient allocation of the authority’s review resources.

The document provides an overview of the applicable regulatory requirements set forth under the existing framework, as well as additional recommendations and clarifications 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 underlying legislation and has been agreed upon with the authority in advance.

Regulatory Considerations: Key Points

The scope of the guidance covers, inter alia, the most important regulatory considerations related to the medical device development tool (MDDT) qualification as well as key recommendations to be taken into consideration in this respect. 

For instance, the authority mentions that some of the device development tools covered by the scope of the present guidance actually meet the definition of a medical device as set forth by the applicable legislation. The final determination will depend on the way the tool is intended to be used. In particular, if the MDDT is only for use in device development or evaluation and is not for use in diagnosing or treating patients or study subjects, it is unlikely that it would be a device; however, if the MDDT is intended for use in diagnosing or treating or aiding in the diagnosis or treatment of subjects in a clinical study or in clinical settings (outside of a clinical study), it would likely be a device and would not be an MDDT. The authority also mentions that sometimes medical device development tools could combine both uses.

Applicable Requirements

As further explained by the authority, under the general rule, most of the requirements related to medical devices would not apply to the products intended to be used solely in the context of a clinical investigation due to the respective exemption, provided, however, that the investigation in question is fully compliant with the respective requirements or also falls within the scope of a specific exemption. Since medical device development tools are usually used in the course of research or studies related to medical devices, the ones subject to regulation as medical devices would still be exempt, subject to the compliance of the clinical investigation itself with the relevant regulatory requirements. 

Moreover, the authority also mentions that the use of an MDDT in a medical device clinical study does not change the Investigational Device Exemption (IDE) requirements for a given investigation, i.e., MDDT qualification does not obviate the need for a device developer to meet existing regulatory requirements or alter the benefit-risk threshold for regulatory decision-making related to a medical device; rather, it can facilitate the development and regulatory evaluation of a medical device by providing a more efficient and predictable means for collecting the necessary information to make regulatory assessments.

Qualification vs Approval or Clearance

The document also provides clarifications regarding the difference in regulatory approach towards qualification of a medical device development tool and clearance or approval for a medical device granted under the respective legal framework. According to the guidance, the difference will be, first of all, in the evidence expected by the authority under each of the abovementioned pathways. When assessing an application for MDDT qualification, the authority will pay attention to the performance characteristics of the tool in question as well as the reliability and reproducibility of the results it provides. At the same time, when deciding on clearance or approval for a medical device, the authority would mostly be focused on substantial equivalence to a similar medical device already placed on the market or aspects related to its safety and effectiveness when used for the intended purpose as specified by its manufacturer. Consequently, the mere qualification of a medical device development tool should not be construed as approval for it to be used for clinical treatment or diagnosis ppurposes.-Asmentioned by the authority, the use of such tests for clinical diagnostic purposes may mislead healthcare prprovidersnd cause serious adverse health consequences to patients, ho are not aware they are being diagnosed or treated based onon theesults of tests with research or investigational products. Thus, the authority encourages the developers of medical device development tools to clearly specify that the latter are not intended to be used in the course of normal clinical practice, nd thould be limited to investigational purposes. The appropriate statements should be included in labeling and any documentation accompanying medical device development tools. In particular, the wording included could clearly state that qualification should not be considered as arance or approval. It Thereould always be a clear separation between medical device development tools and medical devices in order to avoid confusion. 

The medical device development tools qualification program is not intended to replace the use of consensus standards and the relevant recognition process; as it was mentioned before, the MDDT program is complementary in nature. 

In summary, the present FDA guidance outlines certain specific considerations related to the regulatory status of medical device development tools in comparison to medical devices. The document explains the approach to be applied to ensure the safety of patients and prevent the use of MDDTs in clinical practice.

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