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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.

De Novo
	New section 513(f)(2) - Evaluation of Automatic Class III Designation: Guidance for Industry and CDRH Staff; Final

Debarment
	Debarment List

Defibrillators
	Air Aid: Medical Kits Reach New Heights
	Consumer Information for the Medtronic InSync Biventricular Pacing System
	FDA Approves Lower Cost Implantable Defibrillator
	FDA Approves New Indication for Implantable Cardioverter Defibrillators
	FDA Approves New Type of Defibrillator
	FDA Approves New Wearable Defibrillator for Seriously Ill Heart Patients
	FDA Clears First External Defibrillator for Use on Young Children
	Implanted Defibrillators and Pacemakers: A Gentler Jolt and Tickle for Trembling Hearts
	Important Information on Anti-Theft and Metal Detector Systems and Pacemakers, ICDs, and Spinal Cord Stimulators
	Laerdal Defibrillators
	Photon DR Implantable Cardioverter Defibrillator
	Phylax AV Implantable Cardioverter Defibrillator with Program Software
	Summary for Medtronic Jewel Implantable Defibrillator
	Summary information for Defender II Model 9201 Implantable Cardioverter Defibrillator - P980049
	Summary on LIFECOR Wearable Defibrillator
	When Heartbeats Go Haywire: New Treatments Can Save Lives

Degenerative Disc Disease
	FDA Approves First Device to Utilize Genetically Engineered Protein to Treat Degenerative Disc Disease

DEHP
	Consumer Update - DEHP in Plastic Medical Devices
	FDA Public Health Notification: PVC Devices Containing the Plasticizer DEHP
	Medical Devices Made With Polyvinylchloride (PVC) Using the Plasticizer di-(2-Ethylhexyl)phthalate (DEHP); Draft Guidance for Industry and FDA
	Presentation: PVC and DEHP
	Safety Assessment of di-(2-ethylhexyl)phthalate (DEHP) Released from PVC Medical Devices

Delivery Systems
	Innovative Systems for Delivery of Drugs and Biologics: Scientific, Clinical, and Regulatory Challenges; Public Workshop - July 8, 2003 - Presentations and Transcript

Densitometer
	Draft Guidance for Review of Bone Densitometer 510(k) Submissions

Dental
	Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of FDA Submissions for Orthopedic and Dental Endosseous Implants
	Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices - Guidance for Industry and FDA Staff
	Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA
	Consumer Update: Dental Amalgams
	Dental Cements - Premarket Notification; Final
	Dental Impression Materials - Premarket Notification; Final
	Dental Laser Facts
	Dental More Gentle with Painless 'Drillings' and Matching Fillings
	Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Dental Bone Grafting Material
	FDA Clears First Laser for Treating Tooth Decay
	FDA Public Health Notification: Lead Exposure from Dental Films Stored in Lead-Lined Table-top Containers
	Guidance for the Preparation of Premarket Notifications for Dental Composites

Dental Alloys
	Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Base Metal Alloys
	Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Noble Metal Alloys

Dental Cements
	Dental Cements - Premarket Notification; Final

Dental Composites
	Guidance for the Preparation of Premarket Notifications for Dental Composites

Dental Films
	FDA Public Health Notification: Lead Exposure from Dental Films Stored in Lead-Lined Table-top Containers

Dental Implants
	Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of FDA Submissions for Orthopedic and Dental Endosseous Implants
	Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff

Dental Impression
	Dental Impression Materials - Premarket Notification; Final

Dental Use of Lasers
	Dental Laser Facts
	Dental More Gentle with Painless 'Drillings' and Matching Fillings
	FDA Clears First Laser for Treating Tooth Decay

Dental, Infection Control and General Hospital
	Dental Handpiece Sterilization (Dear Doctor Letter)
	Guidance Document on Dental Handpieces
	OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits; Final

Denture Cushions
	OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits; Final

Dermabrasion
	Guidance for Dermabrasion Devices; Final

Design Control
	Design Control Guidance for Medical Device Manufacturers
	Design Control Inspection Results 6/1/97 - 6/1/98
	Design Control Inspectional Strategy Report Evaluation
	Do It By Design - An Introduction to Human Factors in Medical Devices
	GMP Information / Quality Systems Information

Desktop Video Conferencing
	Desktop Video Conferencing - General Information

Device Advice
	Device Advice: the CDRH self-service site for medical device and radiation emitting product information

Device Classification
	Device Classification
	Preamendments Class III Strategy

Device Evaluation Information
	Device Evaluation Information

Device Experience Netrwork (DEN)
	Search the CDRH Device Experience Netrwork (DEN) Database Informationon Medical Devices for theYears 1992-96

Device Import Alerts
	Medical Device Import Alerts

Device Listing
	Device Listing Database
	Registration and Listing for Firms

Diabetes
	Advisory Panel Recommendation on GlucoWatch�, December 21, 1999
	Approval Information for the GlucoWatch Biographer
	Clinical Chemistry and Clinical Toxicology Devices Panel Meeting Summary for October 29, 2001
	Diabetes Information
	Diabetes: A Growing Public Health Concern
	Encouraging Women to Take Charge of Diabetes
	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
	FDA Clears Home Glycated Hemoglobin Test For Diabetics
	FDA Consumer Article; Diabetes Demands a Triad of Treatments
	FDA Consumer Article; FDA Clears First At-Home Laser for People with Diabetes
	GlucoWatch - FDA Approves New Glucose Test for Adult Diabetics
	Insulin Key to Diabetes, But Not Full Cure
	New Products to Treat Diabetes - FDA Helps Counter a Major Public Health Threat

Diagnostic Devices
	FDA Clears Lab Test for Congestive Heart Failure
	FDA Clears Lab Test for Group B Strep in Pregnant Women
	FDA Clears New Lab Test to Help Rule Out Heart Attack
	FDA Clears Rapid Test for Aspergillus Infection

Diagnostic Imaging
	FDA Clears Camera Pill to Photograph Small Intestine
	FDA Licenses Diagnostic Agent for Lung Cancer
	Guidance for the Submission of Premarket Notifications for Medical Image Management Devices
	Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
	Resource Manual for Compliance Test Parameters of Diagnostic X-Ray Systems

Diagnostic Tests
	FDA Clears Quick New Lab Test for Pneumonia Antigen
	Frequently Asked Questions About The Oraquick� Rapid HIV-1 Antibody Test
	Home Diagnostic Tests: The Ultimate House Call?
	Laboratory Safety Tip: Performance and Cautions in Using Rapid Influenza Virus Diagnostic Tests
	Modern Diagnostics Help Detect Cancer Early
	Over The Counter In Vitro Diagnostic Devices
	Summary Information on Ventana Medical Systems' PATHWAY � HER 2 - P990081
	Summary Information on Vitros Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators - P000014

Diagnostic Ultrasound
	(See also - Ultrasound)
	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)

Diagnostic X-ray
	Assessment of the Impact of the Proposed Amendments to the Diagnostic X-ray Equipment Performance Standard addressing Fluoroscopic X-ray Systems (Draft)

Dialysis
	Draft Guidance for Hemodialyzer Reuse Labeling
	FDA Investigating Role of Baxter's Recalled Dialyzers in Kidney Dialysis Patient Deaths
	Five Kidney Dialysis Deaths Prompt Baxter/FDA Action
	Guidance for the Content of Premarket Notification for Conventional and High Permeability Hemodialyzers; Final
	Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis
	Important Information Relating to Cellulose Acetate Dialyzers
	Manufacturers and Initial Distributors of Hemodialyzers

Dialyzers
	Draft Guidance for Hemodialyzer Reuse Labeling
	FDA Investigating Role of Baxter's Recalled Dialyzers in Kidney Dialysis Patient Deaths
	Five Kidney Dialysis Deaths Prompt Baxter/FDA Action
	Guidance for the Content of Premarket Notification for Conventional and High Permeability Hemodialyzers; Final
	Important Information Relating to Cellulose Acetate Dialyzers
	Manufacturers and Initial Distributors of Hemodialyzers

Diathermy
	Abbreviated Reports on Radiation Safety for Microwave Products (Other Than Microwave Ovens)- E.G. Microwave Heating, Microwave Diathermy, RF Sealers, Induction, Dielectric Heaters, Security Systems
	FDA Public Health Notification: Diathermy Interactions with Implanted Leads and Implanted Systems with Leads

Dielectric
	Guide for Submission of Information on Industrial Radiofrequency Dielectric Heater and Sealer Equipment Pursuant to 21 CFR 1002.10 and 1002.12 (FDA 81-8137)

Digital Mammography
	Digital Mammography
	Information for Consumers on Digital Mammography in Q & A Format
	Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDA

Dioxins
	Tampons and Asbestos, Dioxin, & Toxic Shock Syndrome

Disclaimer
	FDA Disclaimer

Disclosure
	Financial Interest Form: Certification: Financial Interests and Arrangements of Clinical Investigations FDA Form 3454
	Financial Interest Forms: Disclosure: Financial Interests and Arrangements of Clinical Investigators FDA Form 3455
	Guidance for Industry: Financial Disclosure by Clinical Investigators

Disinfectants/Sterilants
	Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA

Dispute Resolution
	Combination Products - Timeliness of Premarket Reviews - Dispute Resolution Guidance - Draft Gudiance for Industry
	Medical Device Appeals and Complaints: A Guidance on Dispute Resolution
	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

Division of Small Manufacturers Assistance (DSMA)
	Division of Small Manufacturers Assistance (DSMA) - see DSMICA

Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
	Device Advice: the CDRH self-service site for medical device and radiation emitting product information
	DSMICA Staff Directory
	Industry Support Main Page

Dockets
	Dockets - Repository for the Administrative Proceedings and Rule-making Documents

Document Review
	Document Review by the Office of the Chief Counsel (Blue Book Memo G96-1)

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

Drugs of Abuse
	Drugs of Abuse (Collection Kit) Home Use Test Kit
	Drugs of Abuse (Two-Step Test) Home Use Test
	FDA Issues Letter to Various Firms Regarding Marketing Status of Their Drugs of Abuse Tests
	FDA Proposes New Policy for Home Drug Abuse Test Kits
	Premarket Submission and Labeling Recommendations for Drugs of Abuse Screening Tests - Draft Guidance for Industry and FDA Staff

Dura Mater
	Class II Special Controls Guidance Document: Human Dura Mater; Guidance for Industry and FDA Staff
	Guidance Document for Dura Substitute Devices; Final Guidance for Industry

Dystonia
	FDA Grants Expanded Use of Brain Implant for Movement Disorder

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Center for Devices and Radiological Health / CDRH