Medical Device Development Tool (MDDT)
“The FDA’s MDDT program is a way for the FDA to qualify tools that medical device sponsors can use in the development and evaluation of medical devices. Qualification means that the FDA has evaluated the tool and concurs with available supporting evidence that the tool produces scientifically plausible measurements and works as intended within the specified context of use.” For more information about the context of use, please view the FDA’s MDDT program page.
The MDDT submission and qualification process are not drastically different from a medical device submission, except the purpose of the MDDT is to *support* regulatory decision-making (an MDDT is not a medical device). An MDDT is reviewed by FDA/CDRH as a medical device is reviewed.
The MDDT program reduces the regulatory burden and promotes efficient medical device development. “ This program streamlines the medical device development and review process by advancing the development and use of scientifically validated and qualified methods, materials, and measurements for assessing how devices work. Before creation of the MDDT program, tools used by developers were evaluated on case-by-case basis — for each medical device submission. This added uncertainty, delay and inconsistency to the process, as well as additional costs and time to innovators and the FDA. The use of a qualified tool also allows FDA regulators to concentrate on the most important aspects of the process and ensure that the end products are developed in a safe and timely manner. And, by qualifying tools for a specific use, the FDA facilitates their application for multiple medical device submissions and manufacturers, delivering greater efficiency and consistency to the community.”
“Once an MDDT is qualified for a specific context of use, FDA’s expectation is that it can be used by any medical device developer for that context of use. CDRH reviewers should accept the MDDT for the qualified context of use without the need to reconfirm the suitability of the MDDT.”
The three Categories of MDDT’s:
- Clinical Outcome Assessment: measures of how a patient feels or functions. These could be patient-reported or clinician-reported rating scales like the NIH stroke scale, measures based on clinical decision-making, observer-reported outcomes such as from a parent or caregiver, or performance outcome measures, such as measures of gait speed or memory recall.
- Biomarker test: A lab test or instrument used to detect or measure an indicator of biologic processes or pharmacologic responses to treatment (biomarker).
- HTT is a biomarker test!