About FDA
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Appendix B: FDA Internet Locations of Guidances Issued for Industry in FY 2009
FY 2009 MDUFA Performance Report Table of Contents
The list below provides the links to the guidances presented in the Overview of MDUFMA I and MDUFA II section of this report.
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- Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties - Manufacturer's Notification of the Intent to Use an Accredited Person under the Accredited Persons Inspection Program Authorized by Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)
Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria - Guidance for Industry, FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision
- Draft Guidance for Industry and FDA Staff - Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Expander - Guidance for Industry, FDA Staff - Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300
Guidance for Industry: Designation of Special Controls for Male Condoms Made of Natural Rubber Latex (21 CFR 884.5300); Small Entity Compliance Guide Draft Guidance for Industry and FDA Staff: Investigational Device Exemption (IDE) Guidance for Retinal Prostheses Guidance for Industry and FDA Staff - Procedures for Handling Post-Approval Studies Imposed by PMA Order (PDF Version) (PDF - 111KB)
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