On June 24, 2020, there was an update to the current status of FDA’s MDDT program. CDRH announced a new tool had qualified as MDDT. This is only the sixth tool to qualify since the MDDT Guidance document was finalized in 2017. See the list of qualified tools here: https://www.fda.gov/medical-devices/science-and-research-medical-devices/medical-device-development-tools-mddt.
What is the Medical Device Development Tools (MDDT) program?
The FDA has described the MDDT program as a way for the agency to qualify tools for a specified context of use in the development and evaluation of medical devices. Those results may then be “relied upon in device evaluation and to support regulatory decision-making,” according to the 2017 MDDT guidance, accessible here: Qualification of MDDT – Guidance. To qualify a tool, the FDA is looking for evidence that the tool produces “scientifically-plausible measurements and works as intended within the specified context of use.” Only then would CDRH reviewers accept the MDDT for the qualified context of use “without the need to reconfirm the suitability and utility of the MDDT when used in a CDRH regulatory submission.”
Several factors may be considered by the FDA in their qualification decision-making process. A tool is more likely to be qualified if:
- MDDT is adequately described
- Proposed context of use is adequately & appropriately defined
- Scope & use of the tool would have a broad public health impact
- Evidence demonstrates the MDDT reliably & accurately measures what is intended, what is scientifically plausible, and what is reasonably likely to predict the outcome of interest
- Advantages outweigh potential disadvantages of making decisions based on measurements obtained using the MDDT
The FDA has suggested three categories of MDDT, which provides some insight into the type of tools they imagine would qualify for the program. The first type of tool, clinical outcome assessments (“measures of how a patient feels or functions”), are most likely to be patient questionnaires or outcome rating scales. The second type, biomarker tests (“a lab test or instrument used to detect or measure an indicator of biologic processes or pharmacologic responses to a treatment”), would likely cover diagnostic or patient selection aids like blood pressure measurement instruments or assays to detect the level of an analyte. The third type, nonclinical assessment models (a method or model “that measures or predicts device function or performance in a living organism”), implicate computer and in vitro modeling.
A cautionary note: remember that an MDDT qualification is different from clearance or approval of a medical device. Under the MDDT program, the FDA evaluates the tool’s validity and predictability; but for clearance or approval, the FDA evaluates substantial equivalence or whether the device has a reasonable assurance of safety and effectiveness. A manufacturer with a tool qualified under the MDDT program should not market the tool as “approved”; the MDDT program simply provides assurance of the suitability of the tool in the specified context when CDRH engages in a final review of the medical device.
Why have stakeholders been slow to participate in the MDDT program?
The FDA’s stated goal with the MDDT program is to “assess and refine the qualification process for tools used to develop and evaluate medical devices.” Furthermore, in an effort to support the use of tools in regulatory evaluation, once an MDDT is qualified for a specific context of use (COU) the FDA “intends to accept its use by any medical device sponsor for that COU.” This emphasis on publicly available qualified tools may make some manufacturers hesitant to embrace the MDDT program. Although the 2017 MDDT guidance merely encouraged developers to make their qualified MDDTs publicly available, the current stance on the MDDT webpage linked above states that, “The FDA only intends to qualify tools where the information contained in the summary of evaluation and basis for qualification can be made public.” This may explain why 3 of the 6 qualified tools at this point have been patient questionnaires.
The MDDT program has the potential to make regulatory submissions more streamlined, if manufacturers buy in to this sort of “pre-approval” of tools. While the current status of FDA’s MDDT program is one of slow growth, it will be interesting to see what tools are approved in the coming months. Tool developers, medical device manufacturers, or others who do wish to participate in the MDDT program need only submit an eCopy proposal to CDRH which includes a “description of the MDDT, and a justification for how the MDDT will help address a public health need.” The voluntary program does not require any fees. CDRH may even accept MDDTs that are not fully developed if they have a high potential public health impact (the agency would then work with the submitter to foster development of the tool during an “incubator phase”).
See our post from last year on MDDT: FDA Medical Device Development Tool (MDDT) Qualification
