2009 Guidance Documents

Title	Organization	Doc #	Date
Guidance for Industry and FDA Staff - In Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency	OIVD	1706	11/06/09
Draft Guidance for Industry and FDA Staff: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions	OSEL/DRARD/RDB	1697	10/21/09
Draft Guidance for Industry and FDA Staff: Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions	OSEL/DIAM	1698	10/21/09
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Cardiac Allograft Gene Expression Profiling Test Systems	OIVD/DCTD	1686	10/21/09
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Wound Dressing with Poly(diallyl dimethyl ammonium chloride) (pDADMAC) Additive	ODE/DGRND/PRSDB	1684	10/16/09
Draft Guidance for Industry, MQSA Inspectors and FDA Staff - The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13	OCER/DMQRP	1695	10/09/09
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Assays	OIVD/DMD	1672	10/09/09
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay	OIVD/DMD	1669	10/09/09
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays	OIVD/DMD	1673	10/09/09
Guidance for Industry and FDA Staff - Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007	OC/DRMO/RPSB	1657	10/08/09
Draft Guidance for Industry and FDA Staff - Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation	ODE/DCD/CEMB	1708	09/14/09
Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems	OIVD/DMD	631	08/28/09
Guidance for Industry and FDA Staff - User Fees and Refunds for Premarket Notification Submissions (510(k)s)	CBER CDRH	1511	08/27/09
Draft Guidance for Industry, User Facilities and FDA Staff: eMDR - Electronic Medical Device Reporting	OSB/DPS	1679	08/21/09
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	CBER CDRH	1200	08/06/09
Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff	ODE/DAGID/DEDB	1192	07/28/09
Presenting Risk Information in Prescription Drug and Medical Device Promotion
User Fees and Refunds for Premarket Approval Applications	CBER CDRH	1681	03/13/09
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)	CBER CDRH	1532	03/02/09
Assay Migration Studies for In Vitro Diagnostic Devices	CBER CDRH/OIVD	1660	01/05/09
Draft Guidance for Industry and FDA Staff: Investigational Device Exemption (IDE) Guidance for Retinal Prostheses	ODE/DOED/VEDB	1651	04/17/09
Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products	ODE/DOED/ENTB	1696	02/25/09
Guidance for Industry: Designation of Special Controls for Male Condoms Made of Natural Rubber Latex (21 CFR 884.5300); Small Entity Compliance Guide	ODE/DRARD/OGDB	1693	01/05/09
Recommendations for Anti-Nuclear Antibody (ANA) Test System Premarket (510(k)) Submissions	OIVD/DIHD	848	01/22/09
Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA	OIVD/DMD	1665	01/02/09