Any tool developer, medical device sponsor, or others, such as research organizations and academia can voluntarily submit a proposal for a Medical Device Development Tool (MDDT). The program aims to provide MDDT developers and medical device sponsors with a mechanism for discussing early concepts about a tool and facilitating increased adoption and use of qualified tools.

MDDT Proposal Qualification Plan: Example Content

Cover Letter

As part of all MDDT submission packages, the FDA recommends including a cover letter with the following high-level information to help identify the submission as an MDDT.

• Submission Type: List "MDDT Proposal Phase: Universal Tracking Number (UTN) Request"
• MDDT Name: Identify the name of the MDDT in the submission. Note that this should be the official name of the MDDT.
• MDDT Type: Include the MDDT Type, which can be a Non-clinical Outcome Measurement, Biomarker Test, Clinical Outcome Assessment, or other.
• Context of Use (COU):  Include the proposed context of use statement for your MDDT. It is important to ensure that the proposed context of use is the same throughout the rest of your proposal to avoid any confusion about the scope of the MDDT proposal.
• Previous Submission: Indicate whether the tool has been previously submitted to the MDDT Program or to the Drug Development Tool (DDT) Program. Add details and provide the previous MDDT Q-submission or UTN number.
• Requestor Information: Include the requestor name, requestor's organization, mailing address, email address(es), and phone number(s).

MDDT Proposal Package

The MDDT Proposal Package should contain sufficient information to understand the nature of the MDDT and how the MDDT can facilitate regulatory decision making. As outlined in the Qualification of Medical Device Development Tools (MDDTs) guidance, the FDA recommends including the following information:

• MDDT Description: Include a description of the development tool and how the tool achieves its specified output. This section could include any schematics, photos, figures, engineering drawings, as well as labeling and instructions for use.
• Context of Use (COU): Include what the tool is intended to measure or assess, how the tool should be used, as well as any major limitations or constraints on the applicability of the tool.
• Performance Criteria: Outline the performance criteria that defines the performance characteristics of the tool.
• Qualification Plan: Include a complete plan for collecting evidence to demonstrate that the tool reliably and accurately meets its intended purpose and is scientifically plausible. The plan should include information and protocols to describe how each performance criterion will be addressed.
• Assessment of advantages and limitations: For the proposed COU, outline the advantages and limitations of using the tool to support an assessment of safety, effectiveness, or performance for a medical device.