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The FDA Medical Device User Fee Program: MDUFA IV Reauthorization

Description: This report describes current law regarding medical device user fees, the impact of Medical Device User Fee and Modernization Act (MDUFMA) on Federal Drug Administration (FDA) review time of various medical device applications, and the agency's medical device program budget.
Date: June 6, 2016
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department
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The Food and Drug Administration Safety and Innovation Act (P.L. 112-144)

Description: This report provides a brief policy background narrative and an overview of provisions for each title of the Food and Drug Administration Safety and Innovation Act (FDASIA), P.L. 112-144. The legislation amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the authority of the Food and Drug Administration (FDA) in performing its human drug, biological product, and medical device responsibilities.
Date: August 21, 2012
Creator: Thaul, Susan; Bagalman, Erin; Corby-Edwards, Amalia K.; Glassgold, Judith M.; Johnson, Judith A.; Lister, Sarah A. et al.
Partner: UNT Libraries Government Documents Department
open access

The Medical Device Excise Tax: Economic Analysis

Description: This report reviews the issues surrounding the medical devices tax within the framework of basic principles surrounding the choice of commodities to tax under excise taxes. The next section describes the tax and its legislative origins. After that, the report analyzes the arguments for retaining and repealing the tax.
Date: January 9, 2015
Creator: Gravelle, Jane G. & Lowry, Sean
Partner: UNT Libraries Government Documents Department
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