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FDA Guidance Documents - 2005 Releases
| Draft Guidance for Industry and FDA Staff: Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens |
December 8, 2005 |
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| Guidance for Industry and FDA Staff - Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 CFR 1040.30) |
November 17, 2005 |
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| Federal Register: Medical Devices; A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff; Availability |
November 11, 2005 |
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| Guidance for Industry and FDA Staff - A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures |
November 10, 2005 |
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| Draft Guidance for Industry and FDA Staff: Tinnitus Masker Devices - Class II Special Controls Guidance Document |
November 7, 2005 |
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| Guidance for Industry and FDA Staff - The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #10 |
November 4, 2005 |
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| Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner |
November 4 , 2005 |
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| Guidance for Industry and FDA Staff: Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions |
October 31 , 2005 |
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| Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: CFTR Gene Mutation Detection Systems |
October 25 , 2005 |
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| Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended--Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices - Draft Guidance for Industry and FDA Staff |
October 10 , 2005 |
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| Draft Guidance for Industry and FDA Staff - Functional Indications for
Implantable Cardioverter Defibrillators |
October 6 , 2005 |
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| Guidance for Industry and FDA Staff - Mammography Facility Surveys, Mammography Equipment Evaluations, and Medical Physicist Qualification Requirements under MQSA |
October 5 , 2005 |
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| Class II Special Controls Guidance Document: AFP-L3% Immunological Test
Systems |
October 4 , 2005 |
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| Guidance for Industry - Review Criteria for Assessment of C-Reactive Protein
(CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive
Protein (cCRP) Assays |
September 26 , 2005 |
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| Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties: Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002 |
September 16 , 2005 |
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| Draft Guidance for Industry and FDA Staff: Procedures for Handling Post-Approval Studies Imposed by PMA Order |
September 16 , 2005 |
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| Draft Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988
(CLIA) Waiver Applications
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September 6 , 2005 |
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| Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Ribonucleic Acid
Preanalytical Systems (Ribonucleic Acid Collection, Stabilization and
Purification Systems for Real Time Polymerase Chain Reaction Used in
Molecular Diagnostic Testing); Availability |
August 26, 2005 |
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| Guidance for Industry and FDA - FY 2006 MDUFMA Small Business Qualification Worksheet and Certification |
August 18, 2005 |
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| Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s |
August 16, 2005 |
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| Guidance for Industry, MQSA Inspectors, and FDA Staff - The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #11 |
August 15, 2005 |
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| Guidance for Industry and FDA Review Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)] |
April 22, 2005 |
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| Guidance for Industry and FDA Staff: Application User Fees for Combination Products |
April 21, 2005 |
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| Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software |
January 18, 2005 |
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