Today, the Food and Drug Administration (FDA) released a draft guidance, Medical Device Development Tools: Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff. Once finalized, this policy will support the development and timely evaluation of innovative medical devices.
An MDDT is a scientifically validated tool – 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 non-clinical assessment method or model (e.g. in vitro, animal or computational model) - that aids device development and regulatory evaluation.
The guidance describes a process for “qualification” of an MDDT, which reflects the FDA’s determination that within a specified context of use (the use parameters for which the MDDT has been validated); the results of an assessment that uses an MDDT can support device development and regulatory decision-making. Definitions of applicable terms, criteria for evaluating an MDDT for a specific context of use, considerations for qualification, and the required contents of a qualification submission are also included.
The guidance does not discuss the review of MDDTs submitted as part of a premarket regulatory submission for a specific medical device, nor does it address the specific evidentiary or performance expectations for the qualification of a specific MDDT.
Once an MDDT is qualified for a specific context of use, the FDA’s expectation is that it could be used by any medical device developer for that context of use. The FDA will accept the MDDT for the qualified context of use without the need to reconfirm the suitability of the MDDT. However, the existence of a qualified MDDT would not require that the tool be used during the device development or regulatory evaluation process. Other scientifically valid tools or approaches may also be used. Once the guidance is final, the FDA will make MDDT qualification decisions public by posting qualified MDDTs on its website.
You may submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.