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