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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.

Ultrahigh Molecular Weight Polyethylene
	Draft Data Requirements for Ultrahigh Molecular Weight Polyethylene (Uhmupe) Used in Orthopedic Devices

Ultrasound
	Abbreviated Reports on Radiation Safety of Non-Medical Ultrasonic Products
	Consolidated Review of Submissions for Diagnostic Ultrasound Equipment, Accessories and Related Measurement Devices #G90-2 (blue book memo)
	Consumer Update on Fetal Keepsake Videos
	FDA Approves First Ultrasound Device for Diagnosing Osteoporosis
	FDA Cautions Against Ultrasound 'Keepsake' Images
	Guidance on Electronic Products which Emit Radiation
	Guide for Preparing Annual Reports for Ultrasonic Therapy Products
	Guide for Preparing Product Reports for Medical Ultrasound Products
	Guide for Preparing Product Reports for Ultrasonic Therapy Products (physical therapy only)
	Harmonic Imaging with/without Contrast - Premarket Notification; Final
	Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
	Necessary Information for Diagnostic Ultrasound 510(k) (Draft)

Ultraviolet Radiation
	Guidance on Electronic Products which Emit Radiation

Uncemented Prostheses
	Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis

United States Agents
	United States Agents for Devices

Urinary Spincter
	Draft Guidance for Preparation of PMA Applications for the Implanted Mechanical/Hydraulic Urinary Continence Device (Artificial Urinary Sphincter)

Urinary Tract Infection
	Urinary Tract Infection Home Use Test

Urine Drainage Bags
	Guidance for the Content of Premarket Notifications for Urine Drainage Bags

Urology
	Draft 510(k) Checklist for Non-Implanted Electrical Stimulators Used for the Treatment of Urinary Incontinence
	Draft 510(k) Checklist for Urological Irrigation System and Tubing Set
	Draft Guidance for Clinical Investigations of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH)
	Draft Guidance for Preclinical and Clinical Investigations of Urethral Bulking Agents Used in the Treatment of Urinary Incontinence
	Draft Guidance for Preparation of PMA Applications for the Implanted Mechanical/Hydraulic Urinary Continence Device (Artificial Urinary Sphincter)
	Draft Guidance for the Clinical Investigation of Urethral Stents
	Draft Guidance for the Content of Premarket Notifications for Urological Balloon Dilatation Cathethers
	FDA Approves Stent for Urinary Obstruction in Men
	Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems; Final
	Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters
	Guidance for the Content of Premarket Notifications for Ureteral Stents
	Guidance for the Content of Premarket Notifications for Urine Drainage Bags
	Guidance for the Content of Premarket Notifications for Urodynamic/Uroflowmetry Systems
	Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis
	Safety Alert - Potential Cross-Contamination Linked To Hemodialysis Treatment

User Error
	Checklist: Make Sure the Medical Device You Choose Is Designed for You
	Human Factors Program
	Questions and Answers from the 2/14/2001 Teleconference: Integrating Human Factors Engineering into Medical Device Design and Development
	Reducing Use Error

User Facility Report
	Instructions for completing Semi-Annual Report, Form 3419 (MDR)

User Facility Reporting Bulletins
	User Facility Reporting Bulletins

User Fees
	Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products; Guidance for Industry and FDA
	Bundling Multiple Devices or Multiple Indications in a Single Submission - Guidance for Industry and FDA Staff
	Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002 � Identification of Manufacturer of Medical Devices - Draft Guidance for Industry and FDA Staff
	FDA 3602 - FY2004 MDUFMA Small Business Qualification Certification
	FY 2005 MDUFMA Small Business Qualification Worksheet and Certification - Guidance for Industry and FDA
	Information on the Medical Device User Fee and Modernization Act (MDUFMA) of 2002
	Presentation on Medical Device User Fees
	User Fees and Refunds for Premarket Approval Applications - Guidance for Industry and FDA Staff
	User Fees and Refunds for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff

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Center for Devices and Radiological Health / CDRH