Medical Devices

Webinar - CDRH Final Guidance: Qualification of Medical Device Development Tools - August 24, 2017

       

On Thursday, August 24, from 1:00-2:30 PM ET the FDA hosted a webinar for tool developers and stakeholders interested in learning more about the recommendations in the “CDRH Final Guidance: Qualification of Medical Device Development Tools.” The Medical Device Development Tools (MDDT) program, which the FDA launched as a pilot in 2013, is a voluntary process intended to reduce regulatory burden for tool developers and FDA reviewers through the qualification of tools that can aid in the development and evaluation of medical devices. Qualification means that the FDA has evaluated the tool and concurs with available supporting evidence that the tool produces scientifically-plausible measurements and works as intended within the specified context of use. The context of use depends on the product area, the stage of medical device development, and the role of the tool in device evaluation.

During this webinar, the FDA provided:

  • An overview of the MDDT program;
  • Benefits of MDDT qualification;
  • Clarification about the qualification process for an MDDT; and
  • Regulatory considerations and other recommendations for tool developers.

If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2014, 301-796-7100 or dice@fda.hhs.gov.

Page Last Updated: 01/25/2018
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