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