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U.S. Department of Health and Human Services

Medical Devices

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January 28, 2009 FDA MDUFMA Performance Report - Medical Device Guidance Documents Issued During FY 2009

Through December 31, 2008

First Quarter (October 2008 – December 2008) — 4 Publications

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 — 12/23/2008

Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Expander – 12/22/2008

Draft Guidance for Industry and FDA Staff: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile — 12/12/2008

Guidance for Industry and FDA Staff – Modifications to Devices Subject to Premarket Approval (PMA) – The PMA Supplement Decision–Making Process – 12/11/2008

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