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.
Posted by Tim Sandle
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