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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.

Ob/Gyn
	A&A; Medical, Inc., LifeQuest Medical, Inc., and Rocket USA (A&A;) Recall Information
	All U.S. Condom Manufacturers, Importers and Repackagers
	Condoms: Inspection and Sampling at Domestic Manufacturers and of all Repackers; Sampling from all Importers (Damaska Memo to Field on 4/8/87)
	Draft 510(k) Checklist for Condom Catheters
	Draft Guidance for Industry on Surveillance and Detention Without Physical Examination of Condoms
	FDA Clears Lab Test for Group B Strep in Pregnant Women
	FDA Clears New Female Sexual Therapy Device
	FDA Issues Nationwide / International Alert on Recalled OB/GYN and Surgical Devices Due to Health Risk
	FDA Safety Alert: Recall of Ob/Gyn and Surgical Products Manufactured by A & A Medical/Rocket USA/Lifequest
	FR Notice: Labeling for Menstrual Tampons; Ranges of Absorbency, Change From ``Junior'' to ``Light''
	How to Protect Yourself from AIDS
	Information for a Latex Condom 510(k) Submission for Obstetrics-Gynecology Devices Branch - Draft
	Latex Condoms for Men - Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions
	Letter - Condom Manufacturers and Distributors
	Letter - Manufacturers, Distributors and Importers of Condom Products (included in Condom Packet 398)
	Letter - Manufacturers, Importers, and Repackagers of Condoms for Contraception or Sexually-Transmitted Disease Prevention (Holt)
	Novelty Condoms
	On the Teen Scene: Preventing STDs
	Scientific Review Panel Confirms Condoms are Effective Against HIV/AIDS, but Epidemiological Studies are Insufficient for Other STDs
	Standard Specification for Rubber Contraceptives (Condoms)
	Tampons and Asbestos, Dioxin, & Toxic Shock Syndrome
	Testing guidance for Male Condoms Made from New Material (Non-Latex)
	What Kind of Birth Control is Best for You?

Ob/Gyn Surgical Devices
	A&A; Medical, Inc., LifeQuest Medical, Inc., and Rocket USA (A&A;) Recall Information
	FDA Issues Nationwide / International Alert on Recalled OB/GYN and Surgical Devices Due to Health Risk
	FDA Safety Alert: Recall of Ob/Gyn and Surgical Products Manufactured by A & A Medical/Rocket USA/Lifequest

Obesity
	FDA Approves Implanted Stomach Band to Treat Severe Obesity

Office of Device Evaluation (ODE)
	Device Evaluation Information
	ODE Executive Secretary Guidance Manual G87-3
	ODE Regulatory Information for the Office of Compliance - Information Sharing Procedures #G87-2 (blue book memo)
	ODE Site Visit Program
	ODE Vendor Day Program
	Office of Device Evaluation (ODE) Fiscal Year 1985 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1986 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1987 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1988 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1989 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1990 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1991 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1993 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1994 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1995 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1996 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1997 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1998 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1999 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 2000 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 2001 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 2002 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 2003 Annual Report
	Telephone Communications Between ODE Staff and Manufacturers #I93-1 (blue book memo)

Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
	Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Fiscal Year 2003 Annual Report
	Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Website

Office of Science and Engineering Laboratories (OSEL - formerly OST)
	Office of Science and Technology (OST) Fiscal Year 1995 Annual Report
	Office of Science and Technology (OST) Fiscal Year 1996 Annual Report
	Office of Science and Technology (OST) Fiscal Year 1997 Annual Report
	Office of Science and Technology (OST) Fiscal Year 1998 Annual Report
	Office of Science and Technology (OST) Fiscal Yearl 1999 Annual Report
	Office of Science and Technology (OST) Fiscal Yearl 2000 Annual Report

Ombudsman
	CDRH Ombudsman
	CDRH Ombudsman Annual Report for 2001
	CDRH Ombudsman Annual Report for 2003
	Resolving Scientific Disputes Concerning the Regulation of Medical Devices, A Guide to use of the Medical Devices Dispute Resolution Panel; Final Guidance for Industry and FDA

On-line Sales
	Buying Contact Lenses on the Internet, by Phone or by Mail: Questions and Answers
	Buying Medical Devices Online
	FDA Joins with FTC & Others Against Internet Health Fraud

Ophthalmic
	Accountability Analysis for Clinical Studies for Ophthalmic Devices; Draft
	Approval of CeeOn UV Absorbing Posterior Chamber IOL
	Buying Contact Lenses on the Internet, by Phone or by Mail: Questions and Answers
	Consumer Information for MED-El COMBI 40+ Cochlear Implant System
	FDA Approves 30-Night Continuous Wear Contact Lenses
	FDA Public Health Web Notification: Risk of Bacterial Meningitis in Children with Cochlear Implants
	FDA Safety Alert: Warning Regarding the Use of the AbTox Plazlyte Sterilization System
	Focus Night and Day Contact Lens Safety Information
	Manufacturers and Users of Lasers for Refractive Surgery
	Refractive Implants: Guidance for Investigational Device Exemptions (IDE) and Premarket Approval (PMA) Applications; Draft
	Sunglasses, Spectacle Frames, Spectacle Lens and Magnifying Spectacles
	Vision Correction: Taking a Look at What's New
	Vistakon Soft Contact Lens Safety & Effectiveness Information

Organizational Structure
	Center for Devices and Radiological Health - Organizational Structure

Orthopedic
	510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants
	AFFINITY� Cage System
	Approval Information on the Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis
	Complications Related to the Use of Bone Cement in Treating Compression Fractures of the Spine - FDA Public Health Web Notification
	Consumer Information on the BAK/Cervical (BAK/C�) Interbody Fusion System
	Consumer Information on the UBIS 5000 Bone Sonometer
	Draft Data Requirements for Ultrahigh Molecular Weight Polyethylene (Uhmupe) Used in Orthopedic Devices
	Draft Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Orthopedic Devices-The Basic Elements
	FDA Approves New Spinal Fusion Device
	FDA Approves Shock Wave Device for Severe Heel Pain
	Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Or Bone Cement
	Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements
	Letter to the Health Industry Manufacturers Association
	Letter to the Orthopedic Surgical Manufacturers Association
	Osteoporosis: Are You At Risk (brochure)
	Recall of Zirconia Ceramic Femoral Heads for Hip Implants
	Reviewers Guidance Checklist for Orthopedic External Fixation Devices

OST - Office of Science and Technology
	(See also: Office of Science and Technology (OST))
	Office of Science and Technology (OST) Fiscal Yearl 2001 Annual Report

Osteoarthritis
	Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis

Osteoporosis
	FDA Approves First Ultrasound Device for Diagnosing Osteoporosis
	Osteoporosis: Are You At Risk (brochure)

Over the Counter
	Over The Counter In Vitro Diagnostic Devices

Ovulation
	Ovulation (Saliva Test) Home Use Test
	Ovulation (Urine Test) Home Use Test

Oxygen
	FDA Approves New Fetal Oxygen Saturation Monitor
	FDA Public Health Advisory - Potential for Injury from Medical Gas Misconnections of Cryogenic Vessels
	FDA Public Health Advisory: Explosions and Fires in Aluminum Oxygen Regulators
	Intrapartum Continuous Monitors for Fetal Oxygen Saturation and Fetal pH; Submission Guidance for a PMA; Draft Document

Ozone
	Ozone Generators Generate Prison Terms for Couple

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Center for Devices and Radiological Health / CDRH