Topic Index

Center for Devices and Radiological Health, U.S. Food and Drug Administration

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH
horizonal rule

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.

C F R - See Code of Federal Regulations
	CFR - See Code of Federal Regulations

Calibrators
	Guidance for the Submission of Premarket Notifications for Radionuclide Dose Calibrators; Final

Camera
	FDA Clears Camera Pill to Photograph Small Intestine

Cancer
	FDA Approves New Surgical Sealant for Lung Cancer
	FDA Oncology Tools
	First Drug Device Combined Treatment For Certain Pre-Cancerous Lesions Approved
	Immunomagnetic Circulating Cancer Cell Selection and Enumeration System - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff
	Modern Diagnostics Help Detect Cancer Early
	Summary Information on Ventana Medical Systems' PATHWAY ™ HER 2 - P990081

Capillary Tubes
	Glass Capillary Tubes: Joint Safety Advisory About Potential Risks

Capsule Imaging
	Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA

Cardiac
	Dear Colleague Letter: Interaction Between Minute Ventilation Rate-Adaptive Pacemakers and Cardiac Monitoring and Diagnostic Equipment

Cardiac Ablation Devices
	NAVI-STAR Diagnostic/Ablation Deflectable Tip Catheter

Cardiac Angioplasty Devices
	Cordis Checkmate System
	Novoste Beta-Cath System

Cardiac Pacemakers
	Cellular Phone Interference
	Consumer Information for the Medtronic InSync Biventricular Pacing System
	Electromagnetic Interference (EMI)
	Electromagnetic Interference (EMI) Testing of Medical Devices
	FDA Approves First Pacemaker For Congestive Heart Failure
	FDA Approves New Type of Pacemaker
	Important Information on Anti-Theft and Metal Detector Systems and Pacemakers, ICDs, and Spinal Cord Stimulators
	Keeping Medical Devices Safe from Electromagnetic Interference

Cardiovascular, Respiratory, and Neurology
	Consumer Information on Magnets
	Draft Guidance: Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval
	The Role of Clinical Data in Postmarket Surveillance of Cardiovascular Devices - Workshop Summary

Catheters
	Central Venous Catheters Video Information
	Draft 510(k) Checklist for Condom Catheters
	Draft Guidance for the Content of Premarket Notifications for Urological Balloon Dilatation Cathethers
	Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters
	Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters
	NAVI-STAR Diagnostic/Ablation Deflectable Tip Catheter

Cell Counters
	Immunomagnetic Circulating Cancer Cell Selection and Enumeration System - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff

Cell Lines
	Points to Consider in the Characterization of Cell Lines Used to Produce Biological Products

Cellular Phones
	Cellular Phone Facts - Consumer Information on Wireless Phones
	Cellular Phone Interference
	Cellular Phones - See Mobile Phones
	Cooperative Research and Development Agreement (CRADA) - Health Effects of RF Emissions from Wireless Phones (Mobile Units for Commercial Mobile Radio Services)
	Electromagnetic Interference (EMI) Testing of Medical Devices
	FDA and CTIA To Collaborate On Cell Phone Research
	FDA/CDRH Recommendations for EMC/EMI in Healthcare Facilities
	Keeping Medical Devices Safe from Electromagnetic Interference
	Testing of Hearing Aid Interference from Digital Cellular Telephones

Center for Devices and Radiological Health - General Information
	Activities of FDA's Medical Product Centers in 2001
	Better Health Care with Quality Medical Devices: FDA on the Cutting Edge of Device Technology
	Brochure: Better Health Care with Quality Medical Devices
	Brochure: CDRH - Promoting and Protecting the Public Health
	CDRH Contacts Listing
	Center for Devices and Radiological Health - Facility Locations - Map
	Center for Devices and Radiological Health - Organizational Structure
	Center for Devices and Radiological Health - Overview
	Center for Devices and Radiological Health - Referral List
	Center for Devices and Radiological Health - Staff Directory
	FDA Performance Plan FY2002 - Medical Devices and Radiological Health

Centers For Medicare & Medicaid Services (CMS)
	#D95-2, Attachment A (Interagency Agreement between FDA & HCFA)
	#D95-2, Attachment B (Criteria for Categorization of Investigational Devices (HCFA)
	FDA and CMS: Frequently Asked Questions
	FDA and CMS: Working Together for High Quality Healthcare
	HCFA Reimbursement Categorization Determinations for FDA-approved IDEs
	HCFA/CDRH Letter Regarding Physical Restraint Definition
	Implementation of the FDA/HCFA Interagency Agreement Regarding Reimbursement Categorization of Investigational Devices, Att. A Interagency Agreement, Att. B Criteria for Catergorization of Investigational Devices, & Att. C -List #D95-2 (blue book memo)

Central Venous Catheters
	Central Venous Catheters Video Information

Cervical Cancer
	Draft Guidance for Industry: Electro-optical Sensors for the In Vivo Detection of Cervical Cancer and its Precursors: Submission Guidance for an IDE/PMA
	ThinPrep™ Imaging System

Cervical Cytology
	ThinPrep™ Imaging System

Chemical Indicators
	Premarket Notificaton [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff

Cholesterol
	Cholesterol - Home Use Test
	FDA Approves Device to Lower Cholesterol in Select Patients, FDA Talk Paper

Circumcision Clamps
	Potential for Injury From Circumcision Clamps

Civil Money Penalty Policy
	Civil Money Penalty Policy
	Reduction of Civil Money Penalties for Small Entities; Guidance for Industry and FDA Staff

Class III
	Guidance to Industry Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review; Final
	New section 513(f)(2) - Evaluation of Automatic Class III Designation: Guidance for Industry and CDRH Staff; Final

Classification
	Device Advice Classification Page
	Product Classification Database
	U.S.A. Classification of Medical Devices

Classified Convenience Kits
	Classified Convenience Kits

CLIA
	Clinical Laboratory Improvement Amendments (CLIA)
	Clinical Laboratory Improvement Amendments (CLIA) Database
	FR Notice: CLIA Program; Transfer of Clinical Laboratory Complexity Categorization Responsibility to CDRH
	Guidance for Administrative Procedures for CLIA Categorization
	Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver; Draft Guidance for Industry and FDA

Clinical Investigations
	A Device Clinical Trials Data Bank - Public Health Need and Impact on Industry; A Report to Congress
	Accountability Analysis for Clinical Studies for Ophthalmic Devices; Draft
	Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff
	ClinicalTrials.gov - Clinical Trials Database
	Computerized Systems Used in Clinical Trials
	Device Advice: Clinical Trials and Investigational Device Exemptions
	Disqualified/Restricted/Assurances List For Clinical Investigators
	Draft Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring Committees
	Guidance for Industry: Financial Disclosure by Clinical Investigators
	Guidance for Industry; Collection of Race and Ethnicity Data in Clinical Trials (Draft Guidance)
	Guideline for the Monitoring of Clinical Investigations
	IDE - See Investigational Device Exemptions
	Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators
	Perspectives on Clinical Studies for Medical Device Submissions (Statistical)
	Statistical Guidance for Clinical Trials of Non Diagnostic Medical Devices

Clinical Laboratory
	Clinical Laboratory Improvement Amendments (CLIA)
	Clinical Laboratory Improvement Amendments (CLIA) Database
	Guidance for Administrative Procedures for CLIA Categorization

Clinical Practice
	Good Clinical Practice in FDA-Regulated Clinical Trials

Clinical Trials
	A Device Clinical Trials Data Bank - Public Health Need and Impact on Industry; A Report to Congress
	Acceptance of Foreign Clinical Studies; Guidance for Industry
	Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff
	ClinicalTrials.gov - Clinical Trials Database
	Computerized Systems Used in Clinical Trials
	Device Advice: Clinical Trials and Investigational Device Exemptions
	Draft Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring Committees
	Good Clinical Practice in FDA-Regulated Clinical Trials
	Guidance for Industry; Collection of Race and Ethnicity Data in Clinical Trials (Draft Guidance)
	IDE - See Investigational Device Exemptions

Clinipad
	Recall of Clinipad Sterile Products Used in Prepackaged Procedure Kits and Trays

Clitoral Devices
	Class II Special Controls Guidance Document for Clitoral Engorgement Devices

Cochlear Implants
	Cochlear Implants and Bacterial Meningitis
	Consumer Information for MED-El COMBI 40+ Cochlear Implant System
	FDA Public Health Web Notification: Risk of Bacterial Meningitis in Children with Cochlear Implants

Code of Federal Regulations (CFR)
	Code of Federal Regulations Database
	Code of Federal Regulations on GPO

Collagen
	CosmoDerm™ 1 Human-Based Collagen, CosmoDerm™ 2 Human-Based Collagen and CosmoPlast™ Human-Based Collagen

Collection of Race and Ethnicity
	Guidance for Industry; Collection of Race and Ethnicity Data in Clinical Trials (Draft Guidance)

Color Additives / Dyes
	Color Additive Petitions (p. II-19 of PMA Manual)
	Color Additive Status List (Inspection Operations Manual)
	Color Additives for Medical Devices (Snesko)
	Color Certification Reports
	FDA Public Health Advisory: Reports of Blue Discoloration and Death in Patients Receiving Enteral Feedings Tinted with the Dye, FD&C; Blue No.1
	Summary of Color Additives Listed for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices

Combination Products
	Combination Products - Timeliness of Premarket Reviews - Dispute Resolution Guidance - Draft Gudiance for Industry
	FDA Talk Paper: FDA Proposes Rule on "Combination" Products
	Intercenter Agreement Between the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health - Biologics and Devices
	Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health. Drugs and Devices
	Office of Combination Products

Commercial Distribution
	Commercial Distribution/Exhibit Letter

Communication Systems
	Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Communications Systems (Powered and Non-Powered) and Powered Environmental Control Systems

Compliance Information
	Compliance - General Information
	Compliance Guide for Laser Products (FDA 86-8260)
	Compliance Information
	Compliance Policy Guide
	FDA Export Reform and Enhancement Act of 1996
	FDA/ORA Compliance Policy Guides for Devices
	Inspection of Medical Device Manufacturers; Final Guidance for Industry and FDA
	Reduction of Civil Money Penalties for Small Entities; Guidance for Industry and FDA Staff

Computed Tomography
	Brochure: Full-Body CT Scans - What You Need To Know
	FDA Public Health Notification: Reducing Radiation Risk from Computed Tomography for Pediatric and Small Adult Patients
	Guide for the filing of Annual Reports for X-Ray Components and Systems
	Nationwide Evaluation of X-ray Trends (NEXT) 2000 Protocol for Survey of Computed Tomography (CT)
	Whole Body Scanning Using Computed Tomography (CT)

Computer Aided Diagnosis (CADx)
	Computer Aided Diagnosis - Open Public Workshop Meeting Summary
	ThinPrep™ Imaging System

Computers
	Computer Aided Diagnosis - Open Public Workshop Meeting Summary
	Computer-Controlled Potentially High-Risk Medical Devices - List of Device Types
	Computerized Devices/Processes Guidance - Application of the Medical Device GMP to Computerized Devices and Manufacturing Processes
	Computerized Systems Used in Clinical Trials
	FDA Policy For The Regulation Of Computer Products (DRAFT)
	Glossary of Computerized System and Software Development Terminology, August 1995
	Review of 510(k)s for Computer Controlled Medical Devices #K91-1 (blue book memo)

Condoms
	All U.S. Condom Manufacturers, Importers and Repackagers
	Condoms: Inspection and Sampling at Domestic Manufacturers and of all Repackers; Sampling from all Importers (Damaska Memo to Field on 4/8/87)
	Draft 510(k) Checklist for Condom Catheters
	Draft Guidance for Industry on Surveillance and Detention Without Physical Examination of Condoms
	How to Protect Yourself from AIDS
	Information for a Latex Condom 510(k) Submission for Obstetrics-Gynecology Devices Branch - Draft
	Latex Condoms for Men - Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions
	Letter - Condom Manufacturers and Distributors
	Letter - Manufacturers, Distributors and Importers of Condom Products (included in Condom Packet 398)
	Letter - Manufacturers, Importers, and Repackagers of Condoms for Contraception or Sexually-Transmitted Disease Prevention (Holt)
	Novelty Condoms
	On the Teen Scene: Preventing STDs
	Scientific Review Panel Confirms Condoms are Effective Against HIV/AIDS, but Epidemiological Studies are Insufficient for Other STDs
	Standard Specification for Rubber Contraceptives (Condoms)
	Testing guidance for Male Condoms Made from New Material (Non-Latex)
	What Kind of Birth Control is Best for You?

Consent Decrees
	Abbott Labs Signs Consent Decree with FDA; Agrees to Correct Manufacturing Deficiencies
	Dear Colleague Letter: Abbott Laboratories Consent Decree
	Q’s and A’s – Abbott’s In Vitro Diagnostic Products
	US District Court for Illinois Order Dated 11/19/1999; Abbott Consent Decree - Amendment of Effective Date

Consumer Information
	Catalog of FDA Information for Consumers -- Publications and Audiovisuals
	CDRH Strategic Plan
	Consumer Information on CDRH Topics
	We Want You to Know About Television Radiation

Contact Lenses
	Buying Contact Lenses on the Internet, by Phone or by Mail: Questions and Answers
	Buying Medical Devices Online
	FDA Approves 30-Night Continuous Wear Contact Lenses
	FDA Public Health Web Notification: Non-Corrective Decorative Contact Lenses Dispensed Without a Prescription
	FDA Warns Consumers Against Using Decorative Contact Lenses Obtained Without a Prescription or Professional Fitting
	FDA Warns Consumers Not to Use Decorative Contact Lenses Without Proper Professional Involvement
	Focus Night and Day Contact Lens Safety Information
	Vision Correction: Taking a Look at What's New
	Vistakon Soft Contact Lens Safety & Effectiveness Information

Contacts Listing
	Contacts Listing

Containers
	Draft Guidance for Industry: Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products

Continuing Education
	Improving Patient Care by Reporting Problems With Medical Devices - Article
	Improving Patient Care by Reporting Problems With Medical Devices - Test Questions

Contraceptives
	Premarket Testing Guidelines for Female Barrier Contraceptive Devices also intended to prevent sexually transmitted diseases
	Uniform Contraceptive Labeling; Final

Convenience Kits
	Convenience Kits Interim Regulatory Guidance

Coronary Artery Disease
	FDA Clears New Lab Test to Help Predict Those at Risk of Coronary Heart Disease

Corrections and Removals
	Medical Device Recalls (Corrections and Removals)

Cosmetic Laser Surgery
	Cosmetic Laser Surgery: A High-Tech Weapon in the Fight Against Aging Skin

Cotton
	Letter to Manufacturers/Repackers Using Cotton

Cranial Perforator
	Draft Version Cranial Perforator Guidance

Cranial Stimulators
	Draft Version Guidance for Clinical Data to be Submitted for Premarket Approval Application for Cranial Electrotherapy Stimulators

Critical Device Listings
	Critical Device Listings

Cryogenic Vessels
	FDA Public Health Advisory - Potential for Injury from Medical Gas Misconnections of Cryogenic Vessels

Customer Service
	CDRH Customer ServicePlan

horizonal rule

Center for Devices and Radiological Health / CDRH