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De Novo |
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New section 513(f)(2) - Evaluation of Automatic Class III Designation: Guidance for Industry and CDRH Staff; Final |
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Debarment |
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Debarment List |
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Defibrillators |
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Air Aid: Medical Kits Reach New Heights |
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Consumer Information for the Medtronic InSync Biventricular Pacing System |
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FDA Approves Lower Cost Implantable Defibrillator |
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FDA Approves New Indication for Implantable Cardioverter Defibrillators |
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FDA Approves New Type of Defibrillator |
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FDA Approves New Wearable Defibrillator for Seriously Ill Heart Patients |
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FDA Clears First External Defibrillator for Use on Young Children |
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Implanted Defibrillators and Pacemakers: A Gentler Jolt and Tickle for Trembling Hearts |
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Important Information on Anti-Theft and Metal Detector Systems and Pacemakers, ICDs, and Spinal Cord Stimulators |
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Laerdal Defibrillators |
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Photon DR Implantable Cardioverter Defibrillator |
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Phylax AV Implantable Cardioverter Defibrillator with Program Software |
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Summary for Medtronic Jewel Implantable Defibrillator |
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Summary information for Defender II Model 9201 Implantable Cardioverter Defibrillator - P980049 |
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Summary on LIFECOR Wearable Defibrillator |
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When Heartbeats Go Haywire: New Treatments Can Save Lives |
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Degenerative Disc Disease |
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FDA Approves First Device to Utilize Genetically Engineered Protein to Treat Degenerative Disc Disease |
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DEHP |
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Consumer Update - DEHP in Plastic Medical Devices |
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FDA Public Health Notification: PVC Devices Containing the Plasticizer DEHP |
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Medical Devices Made With Polyvinylchloride (PVC) Using the Plasticizer di-(2-Ethylhexyl)phthalate (DEHP); Draft Guidance for Industry and FDA |
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Presentation: PVC and DEHP |
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Safety Assessment of di-(2-ethylhexyl)phthalate (DEHP) Released from PVC Medical Devices |
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Delivery Systems |
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Innovative Systems for Delivery of Drugs and Biologics: Scientific, Clinical, and Regulatory Challenges; Public Workshop - July 8, 2003 - Presentations and Transcript |
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Densitometer |
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Draft Guidance for Review of Bone Densitometer 510(k) Submissions |
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Dental |
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Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of FDA Submissions for Orthopedic and Dental Endosseous Implants |
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Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices - Guidance for Industry and FDA Staff |
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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 |
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Consumer Update: Dental Amalgams |
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Dental Cements - Premarket Notification; Final |
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Dental Impression Materials - Premarket Notification; Final |
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Dental Laser Facts |
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Dental More Gentle with Painless 'Drillings' and Matching Fillings |
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Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Dental Bone Grafting Material |
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FDA Clears First Laser for Treating Tooth Decay |
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FDA Public Health Notification: Lead Exposure from Dental Films Stored in Lead-Lined Table-top Containers |
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Guidance for the Preparation of Premarket Notifications for Dental Composites |
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Dental Alloys |
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Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Base Metal Alloys |
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Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Noble Metal Alloys |
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Dental Cements |
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Dental Cements - Premarket Notification; Final |
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Dental Composites |
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Guidance for the Preparation of Premarket Notifications for Dental Composites |
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Dental Films |
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FDA Public Health Notification: Lead Exposure from Dental Films Stored in Lead-Lined Table-top Containers |
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Dental Implants |
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Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of FDA Submissions for Orthopedic and Dental Endosseous Implants |
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Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff |
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Dental Impression |
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Dental Impression Materials - Premarket Notification; Final |
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Dental Use of Lasers |
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Dental Laser Facts |
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Dental More Gentle with Painless 'Drillings' and Matching Fillings |
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FDA Clears First Laser for Treating Tooth Decay |
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Dental, Infection Control and General Hospital |
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Dental Handpiece Sterilization (Dear Doctor Letter) |
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Guidance Document on Dental Handpieces |
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OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits; Final |
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Denture Cushions |
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OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits; Final |
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Dermabrasion |
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Guidance for Dermabrasion Devices; Final |
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Design Control |
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Design Control Guidance for Medical Device Manufacturers |
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Design Control Inspection Results 6/1/97 - 6/1/98 |
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Design Control Inspectional Strategy Report Evaluation |
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Do It By Design - An Introduction to Human Factors in Medical Devices |
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GMP Information / Quality Systems Information |
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Desktop Video Conferencing |
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Desktop Video Conferencing - General Information |
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Device Advice |
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Device Advice: the CDRH self-service site for medical device and radiation emitting product information |
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Device Classification |
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Device Classification |
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Preamendments Class III Strategy |
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Device Evaluation Information |
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Device Evaluation Information |
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Device Experience Netrwork (DEN) |
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Search the CDRH Device Experience Netrwork (DEN) Database Informationon Medical Devices for theYears 1992-96 |
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Device Import Alerts |
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Medical Device Import Alerts |
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Device Listing |
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Device Listing Database |
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Registration and Listing for Firms |
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Diabetes |
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Advisory Panel Recommendation on GlucoWatch®, December 21, 1999 |
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Approval Information for the GlucoWatch Biographer |
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Clinical Chemistry and Clinical Toxicology Devices Panel Meeting Summary for October 29, 2001 |
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Diabetes Information |
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Diabetes: A Growing Public Health Concern |
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Encouraging Women to Take Charge of Diabetes |
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FDA Approves GlucoWatch for Children With Diabetes |
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FDA Approves New Glucose Monitoring System for Diabetics |
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FDA Approves New Product for Diabetic Foot Ulcers |
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FDA Approves Watch-Like Device to Monitor Blood Sugar Levels |
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FDA Clears Home Glycated Hemoglobin Test For Diabetics |
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FDA Consumer Article; Diabetes Demands a Triad of Treatments |
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FDA Consumer Article; FDA Clears First At-Home Laser for People with Diabetes |
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GlucoWatch - FDA Approves New Glucose Test for Adult Diabetics |
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Insulin Key to Diabetes, But Not Full Cure |
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New Products to Treat Diabetes - FDA Helps Counter a Major Public Health Threat |
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Diagnostic Devices |
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FDA Clears Lab Test for Congestive Heart Failure |
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FDA Clears Lab Test for Group B Strep in Pregnant Women |
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FDA Clears New Lab Test to Help Rule Out Heart Attack |
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FDA Clears Rapid Test for Aspergillus Infection |
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Diagnostic Imaging |
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FDA Clears Camera Pill to Photograph Small Intestine |
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FDA Licenses Diagnostic Agent for Lung Cancer |
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Guidance for the Submission of Premarket Notifications for Medical Image Management Devices |
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Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers |
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Resource Manual for Compliance Test Parameters of Diagnostic X-Ray Systems |
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Diagnostic Tests |
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FDA Clears Quick New Lab Test for Pneumonia Antigen |
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Frequently Asked Questions About The Oraquick® Rapid HIV-1 Antibody Test |
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Home Diagnostic Tests: The Ultimate House Call? |
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Laboratory Safety Tip: Performance and Cautions in Using Rapid Influenza Virus Diagnostic Tests |
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|
Modern Diagnostics Help Detect Cancer Early |
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Over The Counter In Vitro Diagnostic Devices |
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Summary Information on Ventana Medical Systems' PATHWAY ™ HER 2 - P990081 |
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|
Summary Information on Vitros Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators - P000014 |
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Diagnostic Ultrasound |
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(See also - Ultrasound) |
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Harmonic Imaging with/without Contrast - Premarket Notification; Final |
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Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers |
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Necessary Information for Diagnostic Ultrasound 510(k) (Draft) |
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Diagnostic X-ray |
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Assessment of the Impact of the Proposed Amendments to the Diagnostic X-ray Equipment Performance Standard addressing Fluoroscopic X-ray Systems (Draft) |
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Dialysis |
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Draft Guidance for Hemodialyzer Reuse Labeling |
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FDA Investigating Role of Baxter's Recalled Dialyzers in Kidney Dialysis Patient Deaths |
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Five Kidney Dialysis Deaths Prompt Baxter/FDA Action |
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Guidance for the Content of Premarket Notification for Conventional and High Permeability Hemodialyzers; Final |
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Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis |
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Important Information Relating to Cellulose Acetate Dialyzers |
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Manufacturers and Initial Distributors of Hemodialyzers |
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Dialyzers |
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Draft Guidance for Hemodialyzer Reuse Labeling |
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FDA Investigating Role of Baxter's Recalled Dialyzers in Kidney Dialysis Patient Deaths |
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Five Kidney Dialysis Deaths Prompt Baxter/FDA Action |
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Guidance for the Content of Premarket Notification for Conventional and High Permeability Hemodialyzers; Final |
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Important Information Relating to Cellulose Acetate Dialyzers |
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Manufacturers and Initial Distributors of Hemodialyzers |
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Diathermy |
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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 |
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FDA Public Health Notification: Diathermy Interactions with Implanted Leads and Implanted Systems with Leads |
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Dielectric |
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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) |
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Digital Mammography |
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Digital Mammography |
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|
Information for Consumers on Digital Mammography in Q & A Format |
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|
Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDA |
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Dioxins |
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Tampons and Asbestos, Dioxin, & Toxic Shock Syndrome |
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Disclaimer |
|
FDA Disclaimer |
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Disclosure |
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Financial Interest Form: Certification: Financial Interests and Arrangements of Clinical Investigations FDA Form 3454 |
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Financial Interest Forms: Disclosure: Financial Interests and Arrangements of Clinical Investigators FDA Form 3455 |
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Guidance for Industry: Financial Disclosure by Clinical Investigators |
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Disinfectants/Sterilants |
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Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA |
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Dispute Resolution |
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Combination Products - Timeliness of Premarket Reviews - Dispute Resolution Guidance - Draft Gudiance for Industry |
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Medical Device Appeals and Complaints: A Guidance on Dispute Resolution |
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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 |
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Division of Small Manufacturers Assistance (DSMA) |
|
Division of Small Manufacturers Assistance (DSMA) - see DSMICA |
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|
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 |
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|
Drugs of Abuse |
|
Drugs of Abuse (Collection Kit) Home Use Test Kit |
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|
Drugs of Abuse (Two-Step Test) Home Use Test |
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|
FDA Issues Letter to Various Firms Regarding Marketing Status of Their Drugs of Abuse Tests |
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|
FDA Proposes New Policy for Home Drug Abuse Test Kits |
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|
Premarket Submission and Labeling Recommendations for Drugs of Abuse Screening Tests - Draft Guidance for Industry and FDA Staff |
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|
|
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 |
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|
Dystonia |
|
FDA Grants Expanded Use of Brain Implant for Movement Disorder |
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