FDA urging Congress to reauthorize Medical Device User Fee and Modernization Act; comments sought.

From: Transplant News | Date: May 1, 2007 | Copyright information

The US Food and Drug Administration (FDA) is proposing recommendations to Congress for reauthorizing the Medical User Device Fee and Modernization Act (MDUFMA II), which, if adopted, the agency says would help to ensure that safe and effective medical devices get to patients in a timely manner.

Under the medical device user fee program, the industry covers a portion of the costs of FDA's pre-market review program through a variety of fees. The fees are used in concert...

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