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Nov. 13 -- A draft guidance from the Food and Drug Administration outlined a new voluntary process within the agency's Center for Devices and Radiological Health (CDRH) for manufacturers to qualify medical device development tools (MDDT) for use in device development and evaluation programs.
According to a notice published in the Nov. 14 Federal Register (78 Fed. Reg. 68,459), comments on the draft are due Feb. 12, 2014 (docket FDA-2013-D-1279). The draft is titled “Medical Device Development Tools.”
The FDA in the draft said it believes that using the new process “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.”
According to the agency, an MDDT is a scientifically validated tool--a clinical outcome assessment, a test used to detect or measure a biomarker, or non-clinical assessment method or model--that aids device development and regulatory evaluation.
The draft defined qualification as a conclusion that the results of an assessment that uses an MDDT can be relied upon to support device development and regulatory decision making. In short, the agency wants to make sure the tools used to develop devices are validated.
The FDA in the draft guidance said it has four specific goals for the new process:
• enable faster, more efficient development of important life-saving and health-promoting devices;
• promote the development of tools to facilitate more timely device evaluation;
• provide a mechanism to better leverage advances in regulatory science; and
• more quickly and more clearly communicate to stakeholders important advances in regulatory science that may be leveraged to speed device development and regulatory evaluation.
“CDRH 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context of use, it can be used by any medical device developer for that context of use,” the agency said in the draft guidance.
At some point in the future, the FDA said it may initiate a pilot program for MDDT qualification submissions, which would help inform a final guidance.
According to the FDA, the draft guidance represents a change in its previous policy on qualification.
“Previously, if there was interest in using a particular MDDT for multiple products or different clinical settings, each FDA device review team would typically evaluate the data justifying the MDDT use for each product or setting separately,” the agency said in the draft. If an MDDT is qualified through the new process, “the relevant data supporting the tool would be reviewed thoroughly during this process, so that the MDDT could be relied upon within the qualified context of use in the future, without redundant, detailed review of the suitability of the test.”
The agency in the draft also explained how a tool's “context of use” is important to the qualification process. “Context of use describes the way the MDDT should be used and the purpose of the use. Once an MDDT is qualified, the context of use defines the boundaries within which the available data adequately support use of the MDDT,” the agency said.
Context of use is defined in part by the device or product area for which the MDDT is qualified, the stage of device development and the specific role of the MDDT (diagnosis, patient selection, clinical endpoints), the FDA said.
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The draft guidance is at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM374432.pdf.
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