8/29/2023
Photo by Jair Lázaro on Unsplash
The US Food and Drug Administration (FDA) offers a voluntary program that qualifies tools that sponsors may use in support of the development and evaluation of medical devices known as the Medical Device Development Tools (MDDT) program. Some examples of tools that may be included are electronic patient reported outcomes (ePRO) or wearables. Once tools are qualified by the FDA, the sponsor does not need to requalify if using the tool for the same purpose. The FDA evaluates tools submitted to the MDDT program if they are fit for use for the intended purpose, if the advantages outweigh the limitations, and if the tools are likely to produce scientifically sound data. Tools qualified through the program can be used to support medical devices’ safety, effectiveness, or performance. If using the MDDT qualified tool to support a regulatory submission, the MDDT submission number should be included.
There are three categories of MDDTs.
Non-clinical Assessment Model (NAM)
Biomarker Test (BT)
Clinical Outcome Assessment (COA)
The final guidance “Qualification of Medical Device Development Tools” updated in July 2023 clarifies the CDRH Qualification Decision Framework the steps involved in submitting a tool for the MDDT program. It also describes advantages to the MDDT program including:
Increasing the predictability in evaluating devices and improving efficiency in regulatory decision-making
Modernizing the evaluation process for tools used to support medical device clinical trials
Simplifying tool development and adoption
Single qualification of the tool for each intended use situation
Clinical Pathways offers eLearning and instructor led training for ISO 14155:2020 Medical Device Standard and Drug versus Medical Device: Compare and contrast. Contact us at info@clinicalpathwaysresearch.com for more information about live training, or visit our store for our courses HERE.
- The Clinical Pathways Team
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