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FDA Expects Guidance On Validating Device Development Tools To Speed Approvals

A new FDA draft guidance establishes a voluntary process to validate publicly available device development tools so companies can routinely apply them to facilitate their path to market.

A draft guidance issued Nov. 13 by FDA seeks to speed up the approval pathway for medical devices by introducing a voluntary process to get development tools validated so that any company that wishes can use them.

The draft defines a medical device development tool (MDDT), as a scientifically validated method that aids in device development and...

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