Medical device development tools: helping to speed medical device evaluation and approval

FDA

24 October 2017 - The FDA relies on sound science in its decision-making, which provides medical device innovators with a strong base for their product development. 

Part of good science is relying on tools to efficiently and accurately measure the product’s performance at all points in the process.

Finding those accurate, efficient, and reliable tools can be challenging, especially given the diversity of technology and of medical devices. That’s where FDA’s voluntary Medical Device Development Tools (MDDT) program can help. The FDA can evaluate a tool and decide whether to “qualify” it—which means we can determine if the tool measures what it’s supposed to measure, and does so reliably. FDA only intends to qualify tools where it can make certain high level information about the tools publicly available, so that the device development community can benefit from using tools that they know work.

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Michael Wonder

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Michael Wonder