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Index of CDRH Web Documents

KEY: Links are numbered according to what type of file they point to. 1=Text, 2=PDF, 3=PowerPoint, 4=Word, 5=XML, 6=See Also. 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 
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Some additional items of interest can be found on the Consumer Information page.
 
Warning Letters
* FDA Warning Letters Database [Text]
* Product Recalls, Alerts, and Warnings [Text]
 
Wart Removal
* Wartner Wart Removal System [Text] [PDF]
 
Washers
* CDRH Regulatory Guidance for Washers and Washer-Disinfectors Intended for use in Processing Reusable Medical Devices [Text]
* Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors; Guidance for the Medical Device Industry and FDA Review Staff [Text] [PDF]
* Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities   [PDF]
 
Weight Loss Devices
* FDA Approves Implanted Stomach Band to Treat Severe Obesity [Text]
* Investigators' Reports: Unapproved Body Fat Tester Fetches Weighty Fine [Text]
 
West Nile Virus
* Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus [Text] [PDF]
 
Wheelchairs
* Guidance Document for the Preparation of Premarket Notification [510k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles [Text] [PDF]
* Letter to Industry, Powered Wheelchair Manufacturers from RMJohnson   [PDF]
* Letter to Industry, Powered Wheelchair/Scooter or Accessory/Component Manufacturer from Susan Alpert, Ph.D.,M.D.   [PDF]
* New Wheelchair Keeps People on the Move [Text]
 
Whole Body Scanning
* Whole Body Scanning Using Computed Tomography (CT) [Text]
 
Wireless Medical Telemetry
* Deciding When To Submit a 510(k) for a Change to an Existing Wireless Telemetry Medical Device; Final Guidance for FDA Reviewers and Industry [Text] [PDF]
* Wireless Medical Telemetry - Electromagnetic Interference Concerns and Solutions [Text]
* Wireless Medical Telemetry Risks and Recommendations [Text] [PDF]
 
Wireless Phones
* Keeping Medical Devices Safe from Electromagnetic Interference [Text]
* See - Mobile Phones   [Topic..]
 
Women's Health
* FDA Clears New Female Sexual Therapy Device [Text]
 
Workshops
* Schedule for GMP/QS Workshops with CDRH Participation [Text]
 
Wound and Burn Dressing
* Draft Guidance for the Preparation of a Premarket Notification for a Non-Interactive Wound and Burn Dressing [Text] [PDF]
* Draft Guidance for the Preparation of IDE Submission for Interactive Wound and Burn Dressing [Text] [PDF]
* Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds Developing Products for Treatment [Text] [PDF]
 
Wound Healing Devices
* FDA Approves New Product for Diabetic Foot Ulcers [Text]
 
Wrinkle Removers
* FDA Approves New Product for Facial Wrinkles [Text]
* Restylane™ Injectable Gel [Text]
 
Wrinkles
* Announcement of the 2/28/03 General and Plastic Surgery Devices Panel Meeting [Text]
* CosmoDerm™ 1 Human-Based Collagen, CosmoDerm™ 2 Human-Based Collagen and CosmoPlast™ Human-Based Collagen [Text]
* FDA Approves New Product for Facial Wrinkles [Text]
* FDA Panel Meeting 2/28/03 to Discuss Injectable Wrinkle Treatment [Text]
 

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