The draft guidance describes the framework and process for voluntary CDRH qualification of medical device development tools.
By Jim Dickinson
CDRH has released a draft guidance that outlines a voluntary process for qualifying medical device development tools (MDDT) for use in device development and evaluation programs. The center says it believes this policy will “facilitate the development and timely evaluation of innovative medical devices, by providing a more efficient and predictable means for collecting the necessary information to make regulatory assessments.”
The guidance describes the “framework and process for voluntary CDRH qualification of MDDTs, including definitions of applicable terms, criteria for evaluating an MDDT for a specific context of use, considerations for qualification, and the contents of a qualification submission.”
It says an MDDT is a scientifically validated tool, such as a clinical outcome assessment (e.g., patient-reported or clinician-reported rating scales), a test used to detect or measure a biomarker (e.g., assay for a chemical analyte or medical imaging method), or nonclinical assessment method or model (e.g., in vitro, animal, or computational model) that aids device development and regulatory evaluation. “Qualification reflects CDRH’s expectation that within a specified context of use, the results of an assessment that uses an MDDT can be relied upon to support device development and regulatory decision-making,” the draft guidance says.
CDRH further says it expects the qualification process to “expedite development of publicly available tools which could potentially be used widely in multiple device development programs. 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. Importantly, the existence of a qualified MDDT does not convey a requirement that the tool must be used during the device development or regulatory evaluation process. Other scientifically valid tools or approaches may also be used.”
Jim Dickinson is a contributing editor to MD+DI.
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