Jul 7
New FDA Draft Guidance: the Importance of Literature Search in Writing IDE Protocols
7 Jul, 2016. 0 Comments. News. Posted By: Protocol Builder
The FDA recently released a draft guidance policy categorizing investigational device exemption (IDE) devices. The guidance was developed to assist the Centers for Medicare & Medicaid Services (CMS) in determining whether or not an IDE device should be covered (reimbursed) by CMS. The guidance has significant implications for research sites and investigators who are responsible for developing research budgets. The guidance specifically addresses new devices or approved devices that have been modified for a new use and may pose significant risk. This article addresses the latter — approved devices. The FDA intends to categorize devices based on a set of…