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# FDA Issues Medical Device Development Tool Guidance
- URL: https://www.fdaweb.com/fda-issues-medical-device-development-tool-guidance/
- Published: 2017-08-09T12:00:00.000Z
- Updated: 2026-09-14T22:40:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139340

FDA has released a final guidance, *Qualification of Medical Device Development Tools*, formalizing the medical device development tools (MDDT) program that started with a 2013 pilot. CDRH says it believes the policy will facilitate the development and timely evaluation of medical devices by providing a more efficient and predictable means for collecting the necessary information to support regulatory submissions and associated decision-making.

“The purpose of this guidance is to describe the framework and process for voluntary proposal and qualification of an MDDT, including definitions of applicable terms, criteria for evaluating an MDDT for a specific context of use, considerations for qualification, and the contents of a qualification package,” the document says. “For purposes of this guidance, a submitter is a person, group, consortium, or organization (including the federal government) that takes responsibility for and initiates the MDDT qualification process using the procedures described in this guidance.”

The guidance does not discuss the review of tools that are submitted in individual premarket regulatory submissions for use with a particular medical device, and also does not address the specific evidentiary or performance expectations for the qualification of an individual MDDT submission.

Covered in the document are an overview, definitions of key concepts, CDRH qualification decision framework, CDRH qualification process, and communication of FDA qualification decisions to the public. There also is a sample outline of qualification package contents.