The new article highlights aspects related to the second stage of the application review process and also describes the approach to be applied when making changes to a tool after its qualification.

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 (MDDTs). The document provides an overview of the applicable regulatory requirements set forth under the existing legal framework, 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, 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 existing regulatory framework and has been agreed upon with the authority in advance. 

The program described in the guidance is intended to facilitate the development of new medical devices, reduce the regulatory burden, and also ensure the review resources of the authority are properly allocated. In particular, the document describes in detail the qualification decision framework and the approach the authority applies when reviewing the application and making its decision in this respect. The scope of the guidance covers the two main phases of the above process: Proposal Phase (described in the previous article) and Qualification Phase.

Qualification Phase: Key Points

According to the guidance, during the qualification phase, the authority is going to make a determination of whether the tool in question could be qualified for a specific context of use (COU) indicated by the applicant. For this purpose, the authority will conduct a rigorous review of the evidence submitted by the applicant and all the associated data to determine whether the applicable performance criteria are met and whether everything is in line with the Qualification Plan. It is important to mention that if the performance of the tool does not meet the performance criteria, then CDRH may make a determination to not qualify the tool or may recommend a change to the COU within which the tool can be used to support regulatory decision-making. 

As further explained by the authority, the complete Qualification Package should include:

  • MDDT Description;
  • COU;
  • Qualification Plan;
  • Tool Evidence (the authority mentions that its scope and strength would greatly depend on the respective context of use as well as on the type of a tool itself);
  • Assessment of Advantages and Limitations of Qualifications
  • Summary of Evidence and Basis of Qualification 

According to the guidance, the section related to the tool’s performance should address the following aspects:

  • Tool Performance Characteristics: The applicant is expected to provide data demonstrating that the tool provides accurate enough measurements when used for its intended purpose. The data should be sufficient for the authority to assess the completeness and reliability of the evidence provided. 

As explained by the authority, the specific type of evidence to be provided will depend on the type of tool in question and its context of use, while the range of evidence could include:

  • Design Verification;
  • Simulation results from computational models
  • Bench performance data (including full test reports and protocols);
  • Animal performance data;
  • Clinical data;
  • Human factors testing; and/or
  • Literature articles (the full-text article, a summary, and a description of how the article supports qualification) 
  • Reliability and reproducibility: as it was mentioned before, the evidence provided by the applicant in order to support its claims should be strong and reliable.

Specific Aspects

The document also provides additional clarifications regarding the scope of information to be submitted by the applicant in the context of the assessment of advantages and limitations of qualification. In particular, the assessment of advantages should include such details as:

  • the type of advantage(s). According to the guidance, they may include: significantly accelerating the time to develop and evaluate devices; allowing for shorter or smaller clinical or non-clinical studies; allowing for safer or less invasive, easier, more convenient, or less variable measurements than the alternative; and expediting the development of a novel technology of public health importance. 
  • Magnitude of advantage(s): the assessment of the extent to which the new tool impacts the development process in comparison to other alternatives available, as well as its applicability to novel technologies 

Similar aspects should be addressed by the applicant with respect to the assessments of the limitations of using the tool in question, namely:

  • Type of limitation(s): the applicant is expected to outline specific conditions where the usability of the tool, the accuracy, and the reliability of the results it provides would be limited.
  • Magnitude of limitation(s): the scope of impact of making a decision based on inaccurate conclusions from an MDDT is based on the severity of risk, a comparison of the MDDT to its alternatives, and considering the COU. 
  • Likelihood of limitation(s): when reviewing the submission, the authority would evaluate the likelihood of specific risks occurring, taking into consideration the evidence provided by the applicant. 
  • Mitigation of limitation(s): the applicant should also provide details on specific measures to be taken to mitigate the risks associated with the use of a medical device development tool subject to review.

Potential Changes to Qualification Status

It is also important to mention that, in accordance with the existing regulatory requirements, the applicant is allowed to request changes to the qualification once it has been granted—for instance, due to changes to or expansion of the context the event uses. In case of significant changes, the authority would have to re-evaluate its decision on the qualification of a medical device development to the theol subject to the changes introduced. 

In summary, the present guidance describes in detail the second stage of the application review process, the Qualification Phase. The document highlights the most important aspects to be taken into consideration when determining the applicability of a tool in question and its compliance with the respective requirements.

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