The FDA Medical Device User Fee Program: MDUFA IV Reauthorization

Johnson, Judith A.

Library of Congress. Congressional Research Service.

关键词: Medicine;    Medical technology;    Medical instruments and apparatus;   

RP-ID  :  R44517
RP-ID  :  R44517_2016Jun06

美国|英语

来源: UNT Digital Library

【 摘 要 】

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.