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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.

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

Balloon
	Balloon Valvuloplasty Guidance For The Submission Of an IDE Application and a PMA Application
	Draft Guidance for the Content of Premarket Notifications for Urological Balloon Dilatation Cathethers

Barrier Devices
	Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Guidance for Industry

Batteries
	Battery Guidance

Bed Rails
	Brochure: A Guide to Bed Safety; Bed Rails in Hospitals, Nursing Homes and Home Health Care: The Facts
	FDA Safety Alert: Entrapment Hazards with Hospital Bed Side Rails
	HCFA/CDRH Letter Regarding Physical Restraint Definition
	Hospital Beds and the Vulnerable Patient
	Minutes from the Hospital Bed Safety Workgroup Meeting (HBSW) held March 28-30, 2001
	Summary of the Hospital Beds and the Vulnerable Patient Meeting; February 24-25, 2000; Final Report

Beds
	Brochure: A Guide to Bed Safety; Bed Rails in Hospitals, Nursing Homes and Home Health Care: The Facts
	FDA Public Health Notification: Safety Tips for Preventing Hospital Bed Fires
	FDA Safety Alert: Entrapment Hazards with Hospital Bed Side Rails
	Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Beds
	HCFA/CDRH Letter Regarding Physical Restraint Definition
	Hospital Beds and the Vulnerable Patient
	Minutes from the Hospital Bed Safety Workgroup Meeting (HBSW) held March 28-30, 2001
	Summary of the Hospital Beds and the Vulnerable Patient Meeting; February 24-25, 2000; Final Report

Benign Prostatic Hyperplasia (BPH)
	Draft Guidance for Clinical Investigations of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH)
	FDA Approves New Device to Treat Enlarged Prostate
	FDA Public Health Notification: Serious Injuries from Microwave Thermotherapy for Benign Prostatic Hyperplasia
	Prostate Cancer: No One Answer for Testing or Treatment
	Summary Information on the Approval of TMx-2000 BPH Thermotherapy System

Biliary Stents
	Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents; Final

Biocompatibility
	Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices

Bioengineering
	Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals

Biofeedback
	Draft Version 1 - Biofeedback Devices -- Draft Guidance for 510(k) Content

Biological Indicators
	Premarket Notifications [510(k)] for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA Reviewers

Biologics
	Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals

Biomaterials
	Final Report: Medical Implant Information, Performance and Policies; Biomaterials and Medical Implant Science (BMIS) Workshop - September 19-20, 2002
	Implementation of the Biomaterials Access Assurance Act of 1998; Draft Guidance for Industry and FDA

Biopsy Devices
	Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology

BioResearch
	Bioresearch Monitoring Agreement for PMAs and PDPs
	Bioresearch Monitoring Program

Bioterrorism
	Bioterrorism
	FDA Bioterrorism Act Home Page

Blood
	FDA Approves Lab Tests for Genetic Clotting Risk
	International Workshop on the Standardization of Whole Blood Coagulation Devices

Blood Glucose Monitors
	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 New Glucose Monitoring System for Diabetics
	FDA Approves Watch-Like Device to Monitor Blood Sugar Levels
	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
	Roche Diagnostics Accu Chek Blood Glucose Monitoring System - Class II Recalls

Blood Glucose Test Strips
	Clinical Chemistry and Clinical Toxicology Devices Panel Meeting Summary for October 29, 2001
	Diabetes Information
	Urgent Notice About Recalled Blood Glucose Test Strips

Blue Book Memos
	Fax and E-Mail Communication with Industry about Premarket Files Under Review (A02-01)
	Intercenter Consultative/Collaborative Review Process (#G02-1)
	Overview of ODE Guidance Memoranda

Body Fat Testers
	Investigators' Reports: Unapproved Body Fat Tester Fetches Weighty Fine

Bone
	Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA

Bone Anchors
	Guidance Document For Testing Bone Anchor Devices

Bone Cement
	Complications Related to the Use of Bone Cement in Treating Compression Fractures of the Spine - FDA Public Health Web Notification
	Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Or Bone Cement

Bone Densitometers
	Draft Guidance for Review of Bone Densitometer 510(k) Submissions
	Letter: Notice to Manufacturers of Bone Mineral Densitometers

Bone Distraction Osteogenesis
	Growing Bones: Bone Expansion Treats Facial Deformities�

Bone Graft
	Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Dental Bone Grafting Material

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

Bone Growth
	Guidance Document for Industry and CDRH staff for the Preparation of Investigational Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices; Draft

Bone Sonometers
	Bone Sonometer PMA Applications; Final Guidance for Industry and FDA

Bone Void Fillers
	Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA

Brachytherapy
	Cordis Checkmate System
	Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources
	Novoste Beta-Cath System

Brain Stimulator
	FDA Approves Expanded Use of Brain Implant for Parkinson's Disease
	FDA Approves Implanted Brain Stimulator to Control Tremors
	Neurological Devices Panel, March 31, 2000 - Bilateral Deep Brain Stimulator

Brain Surgery
	FDA Approves New Glue for Use in Brain Surgery

Breast Cancer
	Immunomagnetic Circulating Cancer Cell Selection and Enumeration System - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff
	Mammograms and Breast Cancer Brochure
	Mammograms and Breast Cancer Brochure - Easy To Read Publication

Breast Imaging Devices
	Class II Special Controls Guidance Document: Breast Lesion Documentation System - Guidance for Industry and FDA Staff
	Digital Mammography
	FDA Approves First Digital Mammography System
	FDA Approves New Breast Imaging Device
	Mammograms and Breast Cancer Brochure
	Mammograms and Breast Cancer Brochure - Easy To Read Publication

Breast Implants
	Breast Implant Adverse Events During Mammography
	Breast Implants (FDA Consumer article, Nov. 1995)
	Breast Implants - An Information Update - 2000
	Breast Implants Information
	Brochure of Breast Implants Risks
	Consumer Information on Breast Implants
	FDA News: FDA Provides Pathway for Sponsors Seeking Approval of Breast Implants
	Guidance for Saline, Silicone Gel, and Alternative Breast Implants; Guidance for Industry and FDA
	Mammograms and Breast Cancer Brochure - Easy To Read Publication
	Mentor Consent Decree Vacated
	Patient Informed Decision Labeling for Saline-Filled Breast Implants (Inamed Aesthetics)
	Patient Informed Decision Labeling for Saline-Filled Breast Implants (Mentor Corporation)
	Photographs and/or Illustrations of Breast Implant Complications
	Questions and Answers For Responding toPublic Inquiries: Consent Decree with Mentor Corporation and MentorTexas, Inc. Regarding the Manufacture of Silicone Gel and Saline Breast Implants
	Saline, Silicone Gel, and Alternative Breast Implants - Draft Guidance for Industry and FDA Staff
	Study of Re-operations and Self-Reported Silicone-Gel Breast Implant Rupture (Interview Component)
	Study of Rupture of Silicone Gel-filled Breast Implants (MRI Component)
	Study of Silicone Gel Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women
	Two Firms Get FDA Approval to Continue Marketing Saline-Filled Breast Implants

Breast Prostheses
	Breast Implants (FDA Consumer article, Nov. 1995)
	Breast Implants Information
	Mentor Consent Decree Vacated
	Questions and Answers For Responding toPublic Inquiries: Consent Decree with Mentor Corporation and MentorTexas, Inc. Regarding the Manufacture of Silicone Gel and Saline Breast Implants

Bronchoscopes
	Olympus America Issues Voluntary Recall of Suspect Video Bronchoscopes

Bulletins
	User Facility Reporting Bulletins

Bundling
	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

Buying Medical Products Online
	Agencies Team Up In War Against Internet Health Fraud
	Buying Contact Lenses on the Internet, by Phone or by Mail: Questions and Answers
	Buying Drugs Online: It's Convenient and Private, but Beware of 'Rogue Sites'
	Buying Medical Devices Online
	Consumer Information About Buying Prescription Drugs and Medical Products Online
	FDA And The Internet: Advertising and Promotion of Medical Products, October 16-17,1996 (Meeting Transcripts)
	FDA Joins with FTC & Others Against Internet Health Fraud
	Reporting Unlawful Sales of Medical Products on the Internet

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Center for Devices and Radiological Health / CDRH