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LATE NEWS: Senate clears MDUFMA (Medical Device User Fee and Modernization Act) technical corrections:

This article was originally published in Clinica

Executive Summary

Legislation making technical and clarifying corrections to the Medical Device User Fee And Modernization Act (MDUFMA) cleared the US Senate on November 25 2003. The bill, S 1881, amends a component of the third-party inspection programme that if unchanged would have rendered the programme inoperable. Previous language required companies to certify that foreign countries recognise an FDA inspection and certify that they market their products in a foreign country that recognises the third-party inspector. The correction allows companies to meet one or both requirements. The legislation also creates an 18-month moratorium on the implementation of Section 301 of MDUFMA, requiring all manufacturers to place their name or brand on their device, if feasible. The US House is expected to pass the technical bill by a voice vote when lawmakers return in mid-December to wrap up the last remaining spending bills.

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