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EFS: EFS Working Groups Update 2 Key Resources
The Master Clinical Trial Agreement (MCTA) working group and Informed Consent and Institutional Review Board (ICF) working group within the Early Feasibility Studies (EFS) program have completed updates to two key EFS resources. Building on the 2017 EFS project success, in 2018 the EFS Contracts working group set out, for the first time, to (A) develop an […]
FDA VIP Program Guidance Released
The Draft Guidance entitled “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program” was published today in the Federal Register for a 60-day public commenting period. “The VIP is a voluntary program facilitated through the Medical Device Innovation Consortium (MDIC) that evaluates the capability and performance of a medical device manufacturer’s practices […]
MDIC Publishes Framework on External Evidence Methods for Medical Devices
The Medical Device Innovation Consortium (MDIC), today announced the publication of the MDIC External Evidence Methods (EEM) Framework. This framework, developed by subject matter experts from industry, academia, and the U.S. Food and Drug Administration (FDA), is a document intended to help stakeholders navigate their way through the process of leveraging external data by harnessing […]