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United States laws under review: as well as reauthorisation of the Medical Device User Fee and Modernization Act, other issues are under consideration by the United States Congress. These include the introduction of incentives for the development of medical devices for paediatric care.

Publication: Medical Device Technology
Publication Date: 01-MAY-07
Format: Online
Delivery: Immediate Online Access

Article Excerpt
A process of negotiation

The Medical Device User Fee and Modernization Act (MDUFMA) of 2002 and the fourth installment of Prescription Drug User Fee Act (PDUFA) need to be reauthorised by 30 September 2007. Many in and around the United States (US) Congress are working hard to ensure that these laws are extended for another five years. Negotiations on the medical device programme began in January 2006 and continue as this article goes to print; the outcomes will be reported in a later issue of this magazine. There are also other bills and draft bills being considered in Washington that will have a direct impact on the medical technology industry and may be included in the legislation reauthorising PDUFA and MDUFMA. This...

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