Report to Congress: Labeling Information on the Relationship Between the Use of Indoor Tanning Devices and Development of Skin Cancer or Other Skin Damage
[Text] [PDF]
Agenda and Materials From October 30, 2008 FDA Performance Report [Text] [PDF]
Agenda and Materials From July 30 FDA Performance Report [PDF]
Medical Device User Fees Have Been Reauthorized for Fiscal Years 2008 - 2012 (September 28, 2007) [Text]
All-Hands Notice from Dan Schultz about MDUFMA II (April 16, 2007) [Text]
New Guidance
FY 2009 Medical Device Small Business Qualification and Certification
Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements - Describes the roles of both FDA and industry in an interactive review process of specific medical device submission types.
Information Related to MDUFMA II
Information Related to the MDUFMA FY 2007 180-Day PMA Goal [Text] [PDF]
New Reports
FY 2006 MDUFMA Financial Report [Text] [PDF]
Latest Quarterly Update on FDA Progress Towards Achieving MDUFMA Performance Goals (actions through Sept. 30, 2006) [PDF]
Latest Quarterly Report on Progress Towards Achieving MDUFMA Performance Goals (actions through Sept. 30, 2006) [PDF]
MDUFMA Guidances
|