Final Guidance Adds Tools to Qualify Device Development

Final guidance on a voluntary program for qualifying medical device development tools (MDDT) for the evaluation of devices regulated by CDRH has been reissued by the FDA with minor process clarifications.

The updates streamline the MDDT review process by providing feedback in the proposal phase and removing the optional pre-qualification and incubator phases.

The guidance, originally issued in August 2017, describes the framework for proposal and qualification of an MDDT, including criteria for evaluating an MDDT for a specific use, considerations for qualification and the contents of a qualification package.

Read the final guidance here.

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