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FDA Seeks to Increase Efficiency with Qualification of Medical Device Development Tools

Health Law Update Jennifer J. Hennessy

The FDA has issued draft guidance for public comment on a voluntary process aimed to increase efficiency in developing and evaluating innovative medical devices.[1] Specifically, the draft guidance addresses FDA qualification of medical device development tools (“MDDT”) for use in device development and evaluation.

What is a MDDT?

A MDDT is a scientifically validated tool that aids in device development and regulatory evaluation. MDDTs fit into three categories: (1) clinical outcome assessments that rely on subjective measures of how a patient feels or functions (e.g., patient-reported rating scales); (2) tests used to detect or measure a biomarker (e.g., methods for measuring blood pressure); or (3) non-clinical assessment methods or models (e.g., computational models).

How is a MDDT Qualification Triggered?

A MDDT qualification can be triggered in one of three ways: (1) the FDA identifies an area of need; (2) stakeholders identify an area of need; or (3) a MDDT developer decides to pursue a qualification to allow for broader use of the MDDT across multiple device development programs. The draft guidance includes detailed instructions on submitting MDDT correspondence to the FDA.

How Does the FDA Expect MDDT Qualification to Increase Efficiency?

The FDA expects that once an MDDT is qualified by the FDA for certain use parameters, it could then be used by other developers within those parameters, without the FDA needing to reconfirm the suitability of the MDDT. The FDA states that MDDT qualification will provide a certain “degree of generalizability for use of MDDTs across multiple medical types or clinical disorders.” The generalization will vary depending on the MDDT at issue.

The FDA also suggests that the option of MDDT qualification may result in collaboration by multiple interested parties each with a stake in developing a MDDT for qualification. This collaboration would permit each individual contributor to expend fewer individual resources in the MDDT development.

Per the draft guidance, the FDA will make MDDT decisions public so they can be used by developers. Thus, developers should be aware that information submitted by the developer about the qualified MDDT will be publically available. The draft guidance notes, however, that use of the MDDT by a developer will always be voluntary. Before MDDT qualification decisions are finalized by the FDA, the draft qualification determination would be made available for public comment.

Comments on this draft guidance may be submitted to the FDA through February 12, 2014.

For more information, please contact Jennifer Hennessy at (608) 283-2405 /, or your Quarles & Brady attorney.

[1] FDA, Medical Device Development Tools - Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff, available here (Nov. 14, 2013).