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Center for Devices and Radiological Health, U.S. Food and Drug Administration

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Index of CDRH Web Documents

Topics starting with : 0-9 A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Or, enter a word or phrase to search for in document titles : (Search Help) Some additional items of interest can be found on the Consumer Information page.

Galvanic Skin Response
	Galvanic Skin Response Measurement Devices -- Draft Guidance for 510(k) Content

Gamma Cameras
	FDA Public Health Notice on Failure of Isocam II,Dual-Headed Nuclear Medicine Gamma Camera
	Safety Alert - Supplemental Information Regarding Failure of Isocam II, Dual-Headed Nuclear Medicine Gamma Camera

GAO Reports
	FDA's Mammography Inspections: While Some Problems Need Attention, Facility Compliance is Growing
	GAO Blue Book Report: Medical Device Regulation: Too Early to Assess European System's Value as Model for FDA
	GAO Report: Single-Use Medical Devices: Little Available Evidence of Harm From Reuse, but Oversight Warranted
	Mammography Services: Impact of Federal Legislation on Quality, Access, and Health Outcomes
	Mammography Services: Initial Impact of New Federal Law Has Been Positive
	Medical Device Reporting: Improvements Needed in FDA's System for Monitoring Problems With Approved Devices
	Medical Devices: FDA Review Times, 1989 Through 1996

Gastric Banding
	FDA Approves Implanted Stomach Band to Treat Severe Obesity

Gastroesophageal Reflux Disease (GERD)
	FDA Approves an Implant for Gastroesophageal Reflux Disease
	Summary from the January 2003 Gastroenterology Devices Panel Meeting

General Hospital
	Criteria for Direct Reference CPG - Surgeon's and Patient Exam Gloves
	Draft Medical Glove Guidance Manual
	Guidance for Industry Recidivist Policy
	Import Alert 80-04
	Import Alert 89-04
	Medical Device Exemptions: 510(k) and GMP Requirements

Genetic Tests
	FDA Approves Lab Tests for Genetic Clotting Risk

Germicides
	Pesticide Regulation Notice 94-4 Interim Measures for the Registration of Antimicrobial Products/Liquid Chemical Germicides with Medical Device Use Claims

Global Harmonization
	Global Harmonization Task Force Website

Gloves
	Draft Medical Glove Guidance Manual
	FDA Public Health Advisory: Potential Risk of Spontaneous Combustion in Large Quantities of Patient Examination Gloves
	Guidance for Conducting Stability Testing To Support An Expiration Date Labeling Claim for Medical Gloves; Draft
	Medical Glove Powder Report
	Potential Risk of Spontaneous Combustion in Large Quantities of Patient Examination Gloves
	Premarket Approval Applications (PMA) for Absorbable Powder for Lubricating a Surgeon�s Glove - Guidance for Industry and FDA Staff
	Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products; Final
	Statement by Elizabeth D. Jacobson Acting Director CDRH, FDA, DHS, Before the Subcommittee on Oversight And Investigations Re: regulations of natural rubber latex gloves
	Surgeon's and Patient Examination Gloves; Reclassification and Medical Glove Guidance Manual Availability; Proposed Rule and Notice
	Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves; Guidance for Industry - Draft

Glucose Monitoring
	Advisory Panel Recommendation on GlucoWatch�, December 21, 1999
	Approval Information for the GlucoWatch Biographer
	Brochure - Home Healthcare Medical Devices: Blood Glucose Meters - Getting the Most Out of Your Meter
	Clinical Chemistry and Clinical Toxicology Devices Panel Meeting Summary for October 29, 2001
	Diabetes Information
	FDA Approves GlucoWatch for Children With Diabetes
	FDA Approves New Glucose Monitoring System for Diabetics
	FDA Approves New Product for Diabetic Foot Ulcers
	FDA Approves Watch-Like Device to Monitor Blood Sugar Levels
	Glucose Home Use Test
	GlucoWatch - FDA Approves New Glucose Test for Adult Diabetics
	Insulin Key to Diabetes, But Not Full Cure

Glucowatch
	Advisory Panel Recommendation on GlucoWatch�, December 21, 1999
	Approval Information for the GlucoWatch Biographer
	FDA Approves GlucoWatch for Children With Diabetes
	FDA Approves Watch-Like Device to Monitor Blood Sugar Levels
	GlucoWatch - FDA Approves New Glucose Test for Adult Diabetics

Glue
	FDA Approves New Glue for Use in Brain Surgery

Gonorrhea Test Kits
	Gonorrhea Test Kits Recalled by Abbott Laboratories

Good Clinical Practice
	Good Clinical Practice in FDA-Regulated Clinical Trials

Good Laboratory Practices
	Good Laboratory Practices

Good Manufacturing Practice
	Application of the Device Good Manufacturing Practice (GMP) Regulation to the Manufacture of Sterile Devices
	Comparison Chart: 1996 Quality System Reg vs. 1978 Good Manufacturing Practices Reg vs. ANSI/ISO/ASQC Q9001 and ISO/DI 13485:1996
	Computerized Devices/Processes Guidance - Application of the Medical Device GMP to Computerized Devices and Manufacturing Processes
	GMP Information / Quality Systems Information
	Medical Device Exemptions: 510(k) and GMP Requirements
	Medical Device Manufacturer's Survey Evaluation of FDA Quality System / Good Manufacturing Practice Inspections
	New Policy Concerning PMA Postmarket Inspections of Contract Sterilizers
	Reengineering: Good Manufacturing Practices (GMP) Inspection Process
	Review of NAI/VAI GMP International EIR Pilot
	Schedule for GMP/QS Workshops with CDRH Participation
	Y2K Issue for Production Processes and Quality System Software

Gowns
	Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes

Grassroots
	Presentations Given at the Grassroots Meetings
	Registration and Listing Process Reengineering Team
	Summary of FDA Grassroots Meetings from Minneapolis, Minnesota
	Summary of FDA Grassroots Meetings from Rockville, Maryland
	Summary of FDA Grassroots Meetings from San Jose and Irving California

Guidance Documents
	CDRH Manual for Good Guidance Practices (GGP) Regulations; Final Guidance for FDA Staff
	FDA/ORA Compliance Policy Guides Manual
	Listing of Good Guidance Practices (GGP) Documents
	Third Party Review Information

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