Regulatory Focus™ > News Articles > Medical Device User Fee Act Released For Public Comment

Medical Device User Fee Act Released For Public Comment

Posted 16 March 2012 | By Alexander Gaffney, RAC 

The proposed recommendations for the Medical Device User Fee Act (MDUFA) were cleared by the US Office of Management and Budget this week, clearing their way for release by the US Food and Drug Administration (FDA) and a 30-day public comment period.

The FDA released a notice for the comment period and a public meeting on 15 March including the most recent MDUFA minutes, FDA's MDUFA commitment letter, pre-recorded video presentations and the text of the proposed legislation.

To register for the meeting, please see the following FDA webpage: MDUFA Meeting Registration.

Read more:

Federal Register - Meetings: Medical Device User Fee Act

MDUFA Meetings from Negotiation and Stakeholder Meetings

Public Workship - Medical Device User Fee Program Public Meeting, March 28, 2012

FDA Commitment Letter - Draft

MDUFA Draft Legislation

Mass Device - MDUFMA: White House clears user fee proposal

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