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# CDRH on Device Tools Qualification Benefits
- URL: https://www.fdaweb.com/cdrh-on-device-tools-qualification-benefits/
- Published: 2017-08-30T12:00:00.000Z
- Updated: 2026-09-14T22:45:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139512

A CDRH [webinar](https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm570498.htm?ref=fdaweb.com) on the Medical Device Development Tools (MDDT) voluntary qualification program listed its benefits as **(1)** leveraging advances in regulatory science that help to bridge the gap between research and development of medical devices and the delivery of high quality, safe, and effective devices to patients; and **(2)** a qualified MDDT can be used by multiple sponsors across multiple medical device development programs. CDRH medical device development tools program director **Hilda-Scharen Guivel** told participants that the program’s intent is to promote development and use of tools to streamline device development and regulatory evaluation.

Questions to consider when determining whether to qualify a proposed MDDT, she said, include whether: 

- the MDDT is adequately described;
- the proposed context of use is adequately and appropriately defined;
- the available scientific evidence demonstrates that the MDDT reliably and accurately measures what is intended, is scientifically plausible, and is reasonably likely to predict the outcome of interest; and
- the advantages outweigh disadvantages of making decisions based on measurement obtained using the MDDT within the specified context of use and available strength of evidence.