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FDA Guidance Documents - 2009 Releases
Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products
 March 30, 2009
Draft Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications
 March 13, 2009
Guidance for Industry and FDA Staff: Recommendations for Anti-Nuclear Antibody (ANA) Test System Premarket (510(k)) Submissions
 January 27, 2009
Guidance for Industry: Designation of Special Controls for Male Condoms Made of Natural Rubber Latex (21 CFR 884.5300); Small Entity Compliance Guide
 January 6, 2009
Draft Guidance for Industry and FDA Staff: Assay Migration Studies for In Vitro Diagnostic Devices
 January 2, 2009
 
 

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