Qualification of Medical Device Development Tools (MDDT) – Guidance for Industry, Tool Developers, and Food and Drug Administration Staff
FDA released the final guidance on MDDT which was launched as a pilot plan in 2013 to provide guidance on a voluntary program for qualification of medical device development tools (MDDT) for use in evaluating devices subject to regulation by Center for Devices and Radiological Health (CDRH). 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.
An MDDT is a method, material, or measurement used to assess the effectiveness, safety, or performance of a medical device. An MDDT is scientifically validated and can be qualified for use in device evaluation and to support regulatory decision-making. Examples of MDDTs are clinical outcome assessments, assessments of biomarkers, and nonclinical assessment methods or models. The use of a qualified MDDT by a product sponsor is voluntary.
The process for MDDT qualification can be initiated in one of three ways:
- FDA identifies an area of need and/or calls for development activity in a specific area;
- Need and interest in an area is determined by individual or consortia of stakeholders (may include academia, industry, medical societies, patient groups);
- MDDT developer pursues qualification to foster broad use of the tool, potentially across multiple device development programs.
Some of the advantages of using MDDT may include:
- Significantly accelerating the time to develop and evaluate devices;
- Allowing for shorter or smaller clinical or non-clinical studies;
- Allowing for safer or less invasive, easier, more convenient, or less variable measurements than the alternative;
- Expediting the development of a novel technology of public health importance.
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