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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.

H C F A- Health Care Financing Administration
	Health Care Financing Administration (HCFA) - see Centers for Medicare & Medicaid Services (CMS)

Hair Removal
	Hair Removal Laser Facts

Hand Implants
	FDA Approves New Hand Implant for Quadriplegics

HDE
	HDE - See Humanitarian Device Exemptions

Health Advisories
	Health Advisories and Safety Alerts

Health Fraud
	Agencies Team Up In War Against Internet Health Fraud
	An FDA Guide to Choosing Medical Treatments
	FDA Joins with FTC & Others Against Internet Health Fraud

Health Professionals
	FDA Patient Safety News for Health Care Personnel

Hearing Aids
	Guidance for Industry; Noise Claims in Hearing Aid Labeling; Final
	Implantable Middle Ear Hearing Device; Guidance for Industry and FDA

Hearing Devices
	Brain stem implant to restore some hearing when tumors damage the cranial hearing nerves
	Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS); Guidance for Industry and FDA
	FDA Approves New Implanted Hearing Device
	FDA Plans to Strengthen Hearing Aid Rules
	Implantable Middle Ear Hearing Device; Guidance for Industry and FDA
	Message Sent Loud and Clear to Hearing Aid Marketer
	On the Teen Scene: Enjoy, Protect, the Best Ears of Your Life
	Straight Talk from FDA About Hearing Loss and Hearing Aids
	Summary Information on Nucleus � 24 Auditory Brainstem Implant System - P000015
	Testing of Hearing Aid Interference from Digital Cellular Telephones

Heart
	Consumer Information for the Medtronic InSync Biventricular Pacing System
	Cordis Checkmate System
	FDA Approves New Wearable Defibrillator for Seriously Ill Heart Patients
	FDA Clears 3-lead, pocket-sized ECG devices
	FDA Clears Lab Test for Congestive Heart Failure
	FDA Clears New Interventional Cardiology Device
	FDA Clears New Lab Test to Help Rule Out Heart Attack
	FDA Heart Health Online
	FDA Speeds Approval for WiderUse of Heart Attack Device
	Frequently Asked Questions About Problems With Endovascular Grafts for Treatment of Aortic Abdominal Aneurysms (AAA)
	NAVI-STAR Diagnostic/Ablation Deflectable Tip Catheter
	Novoste Beta-Cath System
	Phylax AV Implantable Cardioverter Defibrillator with Program Software
	Pocket-Sized ECG Machine Cleared By FDA
	Summary Information on Carpenter-Edwards PERIMOUNT Pericardial Bioprosthesis Model 6900 Mitral - P860057/S011

Heart Attack
	FDA Clears New Lab Test to Help Rule Out Heart Attack

Heart Devices
	Consumer Information for the Medtronic InSync Biventricular Pacing System
	Cordis Checkmate System
	FDA Approves Heart Assist Pump for Permanent Use
	FDA Approves New Wearable Defibrillator for Seriously Ill Heart Patients
	FDA Clears 3-lead, pocket-sized ECG devices
	FDA Clears New Interventional Cardiology Device
	FDA Clears Robotic-Like Device for Heart Surgery
	Frequently Asked Questions About Problems With Endovascular Grafts for Treatment of Aortic Abdominal Aneurysms (AAA)
	NAVI-STAR Diagnostic/Ablation Deflectable Tip Catheter
	Novoste Beta-Cath System
	Phylax AV Implantable Cardioverter Defibrillator with Program Software
	Pocket-Sized ECG Machine Cleared By FDA
	Summary Information on Carpenter-Edwards PERIMOUNT Pericardial Bioprosthesis Model 6900 Mitral - P860057/S011

Heating and Cooling Devices
	Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices

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

Hemodialysis
	Draft Guidance for Hemodialyzer Reuse Labeling
	Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems; Final
	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
	Quality Assurance Guidelines for Hemodialysis Devices
	Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA
	Safety Alert - Potential Cross-Contamination Linked To Hemodialysis Treatment

Hepatitis
	Abbott AxSYM� Antibody to Hepatitis C Virus
	Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Hepatits A Serological Assays for the Clinical Laboratory Diagnosis of Hepatitis A Virus
	FDA Talk Paper - FDA Approves First Home Test For Hepatitis C Virus
	Hepatitis C Home Use Test

Hepatitis C Test Kit
	Hepatitis C Home Use Test

Heritable DNA Markers
	Multiplex Tests for Heritable DNA Markers, Mutations and Expression Patterns; Draft Guidance for Industry and FDA Reviewers

Hip Prostheses
	Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis
	Guidance Document For The Preparation of Premarket NotificationFor Ceramic Ball Hip Systems
	Recall of Zirconia Ceramic Femoral Heads for Hip Implants
	Talk Paper: Hip Implants Being Recalled

HIV
	FDA Approves First Oral Fluid Based Rapid HIV Test Kit
	FDA Approves Sculptra for HIV Patients
	Frequently Asked Questions About The Oraquick� Rapid HIV-1 Antibody Test
	HIV Home Use Test

Home Healthcare Devices
	Brochure: Home Healthcare Medical Devices: A Checklist
	CDRH Home Health Care Committee
	Emerging Trends in Medical Device Technology: Home is Where the Heart Monitor Is

Home Monitors
	Class II Special Controls Guidance for Home Uterine Activity Monitors; Final Guidance for Industry and FDA Reviewers
	Letter to Manufacturers of Prescription Home Monitors for Non-Stress Tests

Home Test Kits
	FDA Proposes New Policy for Home Drug Abuse Test Kits
	Over The Counter In Vitro Diagnostic Devices

Hospital Beds
	FDA Public Health Notification: Safety Tips for Preventing Hospital Bed Fires
	Summary Report: Hospital Beds and the Vulnerable Patient Meeting

HPV - Human Papillomavirus
	FDA Approves Expanded Use of HPV Test

Human Allograft Tissue
	FDA Issues Order to Recall Use of Human Tissue Processed at Cryolife, Inc.

Human Chorionic Gonadotropin (hCG)
	Kit Certification for 510(k)s

Human Factors
	Checklist: Make Sure the Medical Device You Choose Is Designed for You
	Do It By Design - An Introduction to Human Factors in Medical Devices
	Draft Report on Medical Device Labeling: Patients' and Lay Caregivers' Medical Device Information and Labeling Needs - Results of Qualitative Research
	Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers
	Human Factors Points to Consider for IDE Devices
	Human Factors Principles for Medical Device Labeling
	Human Factors Program
	Introduction to Human Factors and the Human Factors Engineering Group
	Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management
	Questions and Answers from the 2/14/2001 Teleconference: Integrating Human Factors Engineering into Medical Device Design and Development
	Reducing Use Error
	Write it Right

Human Tissue
	FDA Public Health Web Notification: Human Tissue Processed by Cryolife, Inc.

Humanitarian Use Devices
	Fetal Stent Receives First Humanitarian Use Approval
	HDE - See Humanitarian Device Exemptions
	Humanitarian Device Exemptions (HDE) Regulation: Questions and Answers; Final Guidance for Industry
	Humanitarian Use Devices
	Humanitarian Use Devices (HDE) Checklist for Filing Decision

Humidifiers
	Hazards of Volume Ventilators and Heated Humidifiers

Hyalgan/Synvisc Knee Injection For Osteoarthritis
	Hyalgan
	Synvisc

Hydrobaths
	Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Immersion Hydrobaths

Hydroxyapatite
	510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants

Hypodermic Needles
	Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen Needles
	NeedleZap

Hysteroscopes
	Guidance ('Guidelines') for Evaluation of Hysteroscopic Sterilization Devices
	Hysteroscopes and Gynecology Laparoscopes - Submission Guidance for a 510(k)
	Hysteroscopes and Laparoscopic Insufflators: Submission Guidance for a 510(k)

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Center for Devices and Radiological Health / CDRH