The new article addresses aspects related to the initial proposal and the way it will be assessed by the authority during the acceptance review.

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. For the purpose of the guidance, medical device development tools stand for measurements and approaches to be applied when developing new medical devices, while their qualification applies to their formal recognition by the authority for a specific purpose. In such a way, the authority expects to reduce the regulatory burden, facilitate the development of new medical devices, and also ensure a better allocation of its review resources. 

It is also important to mention that the provisions of the guidance are non-binding in their legal nature and are not intended to introduce new rules or impose new obligations, but rather to provide an overview of the applicable regulatory requirements set forth under the existing framework, as well as additional clarifications and recommendations to be followed by medical device manufacturers and other parties involved in order to ensure compliance. 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.

Qualification Decision Framework: Key Points

First of all, the authority mentions that the voluntary qualification process for medical device development tools described in the present guidance consists of two phases, namely:

  • The Proposal Phase, and
  • The Qualification Phase

With respect to medical device submissions in general, the authority refers to the eCopy procedure to be followed by the interested party, and the respective guidance documents issued by the FDA. The authority also encourages the applicants to use the CDRH Premarket Review Submission Cover Sheet in order to facilitate the submission and review process. In particular, the applicants should also indicate “MDDT” to make sure the submissions are properly attributed.

Proposal Phase

According to the guidance, the first stage of the MDDT qualification process is a proposal page. At this stage, the authority conducts the initial assessment in order to determine whether the development tool in question could be subject to qualification under the respective framework. As further explained by the authority, at this stage it will conduct the initial review of the MDDT Proposal Package submitted by the applicant, subject to the availability of the authority’s review resources. The authority additionally emphasizes its intention to review the proposal even if the tool in question is not fully developed yet. Once, upon completion of the initial review, the proposal is accepted, the authority will proceed with reviewing the Qualification Package, which contains all the data pertaining to the request. 

Thus, in order to apply for an MDDT qualification, an interested party should submit the appropriate proposal. According to the guidance, the said proposal should contain the following elements:

  1. MDDT Description. This section covers the description of a medical device development tool subject to review, detailed enough for the authority to understand the way it operates and is intended to be used, as well as to assess the aspects related to safety, effectiveness, or performance in the context of the regulatory decision-making process. Apart from this, the applicant is intended to indicate the category of the tool (together with the appropriate justification), a statement with references to approved medical devices, a statement with references to all previous submissions, and also a detailed enough description of the way the medical device development tool is expected to achieve the specified output. The above information could be provided as is or accompanied by photos, drawings, and images illustrating specific aspects. 
  2. Context of Use (COU) According to the guidance, this section is the most important and requires strong and reliable evidence to be provided due to the significance of its impact on the qualification in general. Under the general rule, once an MDDT is qualified, the COU defines the boundaries within which the available data adequately supports use of the MDDT; the COU should describe the specific role of the MDDT in device development.
    As further explained by the authority, this section should cover the following aspects:
    • The specific matters the tool is initially intended to assess 
    • The way the tool is intended to be used and its role 
    • There are specific phases of the medical device development process where the tools are supposed to be used. 
    • Any applicable limitations or considerations to be taken into account with respect to the tool in question and its use 
  • Performance criteria. The manufacturer is also expected to outline the performance criteria to be applied with respect to the tool in question, together with the appropriate acceptance criteria to be used in the context of the regulatory decision-making process. 
  • Qualification Plan. The manufacturer should also submit a detailed plan describing the way the necessary evidence will be collected and demonstrating the accuracy and reliability of the output provided by the tool in question. 
  • Assessment of advantages and limitations In particular, the manufacturer should describe the advantages in terms of the impact the tool will have on the regulatory decision-making process and also clarify the limitations related to its use.  

The authority will conduct a rigorous assessment of the proposals submitted in order to identify the ones that have the biggest potential to introduce significant improvements to the regulatory decision-making process. In particular, the authority will take into consideration several key factors, including, inter alia, the following ones:

  • MDDT provides a safety, effectiveness, or performance assessment for novel or innovative technology with no established paradigm for regulatory assessment;
  • MDDT provides an assessment where there are no or poor alternatives due to scientific need (e.g., no consensus standards or established methods);
  • The use of the MDDT allows for less invasive, easier, more convenient, or less variable measurements than the alternative.  

In summary, the present FDA guidance highlights the key points related to the initial proposals and the approach the authority will apply when conducting its review in order to determine eligibility for the MDDT Program. The document also outlines the scope of information to be included in the said proposal in order to ensure its completeness.

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