Sunday, 2 March 2014

FDA's New Guidance On Medical Device Development Tools

The FDA has recently issued a guidance document relating to medical development tools. The policy is intended to support the development and timely evaluation of innovative medical devices.

The guidance describes a process for “qualification” of an MDDT, which reflects the FDA’s determination that within a specified context of use (the use parameters for which the MDDT has been validated); the results of an assessment that uses an MDDT can support device development and regulatory decision-making. Definitions of applicable terms, criteria for evaluating an MDDT for a specific context of use, considerations for qualification, and the required contents of a qualification submission are also included.

For details see: FDA

Posted by Tim Sandle

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