AAMI News September 2017

FDA Finalizes Guidance on Medical Device Development Tools

Three years after launching a pilot, the Food and Drug Administration (FDA) has released final guidance outlining a voluntary program that qualifies the tools the industry uses in medical device development and evaluation.

The program, the agency says, will ultimately result in effective medical devices getting to patients and users faster.

In the guidance document, the FDA’s Center for Devices and Radiological Health (CDRH) describes how to propose and qualify a medical device development tool (MDDT), including definitions of applicable terms, evaluation criteria, considerations for qualification, and the contents of a qualification package.

“CDRH believes that this policy will facilitate the development and timely evaluation of medical devices by providing a more efficient and predictable means for collecting the necessary information to support regulatory submissions and associated decision making,” the center wrote.

CDRH defines an MDDT as “a method, material, or measurement used to assess the effectiveness, safety, or performance of a medical device.” Such scientifically validated tools can be “qualified” and used to support regulatory requests.

“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,” the agency said. Qualified tools can then be used within the same context in the future, reducing the need for additional CDRH review.

The FDA has defined three categories of MDDTs:

  • Clinical outcome assessment, which measures how a patient feels or functions. This could include patient-reported, observer-reported, or clinician-reported rating scales or performance outcome measures, such as measures of gait speed or memory recall.
  • Biomarker test, which is defined as a lab test or instrument used to detect or measure an indicator of biologic processes or pharmacologic responses to a treatment. This could include tests used to aid in diagnosis; for patient selection in clinical trials, such as an assay to detect the level of a specific hormone in serum; or as clinical study endpoints, such as instruments or methods for measuring blood pressure.
  • Nonclinical assessment model, which includes animal or computational models that measure or predict device function or performance in a living organism.

The final guidance does not mention the review of tools submitted in individual premarket submissions for use with a particular medical device nor does it address the specific expectations for the qualification of an individual MDDT submission, according to CDRH.