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FDA Guidance Documents - 2008 Releases
Guidance for Industry and FDA Staff: Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use
 December 30, 2008
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300
 December 22, 2008
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Expander
 December 19, 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Draft Guidance for Industry and FDA Staff: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile
 December 11, 2008
Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process
 December 10, 2008
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300
 November 7, 2008
Guidance for Industry and FDA Review Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]
 September 22, 2008
Draft Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence
September 18, 2008
Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
 September 16, 2008
Guidance for Industry and FDA Staff - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment
 August 21, 2008
Guidance for Industry - Medical Device Tracking; Guidance for Industry and FDA Staff
 August 15, 2008
Guidance for Industry and FDA Staff: Clinical Study Designs for Catheter Ablation Devices for Treatment of Atrial Flutter
 August 7, 2008
Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers
 August 4, 2008
Guidance for Industry, FDA, and Foreign Governments - FY 2009 Medical Device User Fee Small Business Qualification and Certification
 August 1, 2008
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Bone Sonometers
 July 16, 2008
Guidance for Industry and FDA Staff - Surveillance and Detention Without Physical Examination of Condoms
 July 10, 2008
Guidance for Industry and FDA Staff - Surveillance and Detention Without Physical Examination of Surgeons’ and/or Patient Examination Gloves
 July 10 2008
Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters
 May 29, 2008
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System
 May 29, 2008
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin
 May 29, 2008
Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions
 May 29, 2008
Guidance for Industry - Medical Device Tracking; Guidance for Industry and FDA Staff
 May 23, 2008
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays
 May 19, 2008
Guidance for Industry and FDA Staff: Administrative Procedures for CLIA Categorization
 May 6, 2008
Guidance for Industry: Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies (Companion Document)
 March 26, 2008
Guidance for Industry: Coronary Drug-Eluting Stents— Nonclinical and Clinical Studies
 March 26, 2008
Expedited Review of Premarket Submissions for Devices - Guidance for Industry and FDA Staff
 March 3, 2008
Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
 February 28, 2008
Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
 February 22, 2008
Guidance for Industry and FDA Staff: Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions
 February 15, 2008
Draft Guidance for Industry and FDA Staff: Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses
 February 14, 2008
Guidance for Industry and FDA Staff - Medical Glove Guidance Manual
 February 1, 2008
Guidance for Industry and Food and Drug Administration Staff; Clinical Laboratory Improvement Amendments of 1988: Recommendations for Clinical Laboratory Improvement Amendments of 1988: Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Availability
 January 31, 2008
Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
 January 29, 2008
Guidance for Industry and FDA Staff - The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations
 January 7, 2008
Guidance for Industry and FDA Staff - The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program
 January 7, 2008
 
 

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