Search Results for medical device development tools

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Qualifying Medical Device Development Tools: FDA Finalizes 2013 Guidance By Zachary Brennan - Published 09 August 2017

The US Food and Drug Administration (FDA) on Wednesday finalized guidance first drafted in 2013 to formalize a program that qualifies medical device development tools (MDDT) for use in device development and evaluation programs.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices

Tags: MDDT, medical device development tools, FDA guidance

FDA Unveils Pilot Program Aimed at Accelerating Approvals of New Medical Devices By Alexander Gaffney, RAC - Published 14 August 2014

The US Food and Drug Administration (FDA) is looking for some help from the medical device industry in the hopes of eventually creating a process of faster, more efficient and more predictable approvals.

Categories: News, US, CDRH, Clinical, In vitro diagnostics, Medical Devices, Research and development

Tags: MDDT, Medical Device Development Tools, Qualification, MDDT Pilot Program, Regulatory Science