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Index of CDRH Web Documents

Abbott

Abbott Consent Decree

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

Abbreviated 510(k)s

Invitation to Preparers of Abbreviated 510(k)s for Selected Devices

Abdominal

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

Abdominal Exercise Products

Consumer Information on Electronic Muscle Stimulators

Ablation Devices

Clinical Study Designs for Percutaneous Catheter Ablation for Treatment of Atrial Fibrillation - Guidance for Industry and FDA Staff

Thermal Endometrial Ablation Devices (Submission Guidance for an IDE)

AbTox Plazlyte Sterilization System

FDA Safety Alert: Warning Regarding the Use of the AbTox Plazlyte Sterilization System

Accredited Persons

Requests for Inspection by an Accredited Person Under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002 - Draft Gudiance for Industry, FDA Staff, and FDA-Accredited Third-Pa

Acetabular Cup

Draft Guidance Document for Testing Acetabular Cup Prostheses

Acupuncture

Needle Status Reclassification

Administration Sets

Guidance on Premarket Notifications for Intravascular Administration Sets

Adobe Acrobat Reader

Helpful Tips for CDRH Documents in PDF Format

Instructions for Downloading Portable Document Format (PDF) Reader

Adverse Reactions

How to Report Adverse Reactions and other Problems with Products Regulated by FDA

Advertising and Communication

"Help-Seeking" and Other Disease Awareness Communications by or on behalf of Drug and Device Firms - Draft Guidance for Industry

Consumer-Directed Broadcast Advertising of Restricted Devices

Advice

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

Advisory Committee and Panel Meetings

Availability of Information Given to Advisory Committee Members in Connection with CDRH Open Public Panel Meetings; Draft Guidance for Industry and FDA Staff

Brochure: Request for Nominations for Members and Consultants to Serve on FDA's Medical Devices Advisory Committee

Draft Guidance on Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees

Guidance on Amended Procedures for Advisory Panel Meetings; Final

Overview with Links to Upcoming Meetings and Summaries of Recent Meetings

Alarms

Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm

Amalgams

Consumer Update: Dental Amalgams

Extension Comment Period for Dental Amalgam: Request for Information

Request for Public Comment on Dental Amalgam: Request for Information

Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling; Draft Guidance for Industry and FDA

Analyte Specific Reagents

Analyte Specific Reagents; Small Entity Compliance Guidance; Guidance for Industry

Anesthesia Apparatus

Anesthesia Apparatus Checkout Recommendations

Aneurysm Clips

Guidance for Testing MR Interaction with Aneurysm Clips

Aneurysm Repair Devices

Frequently Asked Questions About Problems With Endovascular Grafts for Treatment of Aortic Abdominal Aneurysms (AAA)

Angioplasty

Cordis Checkmate System

How to Keep Your Heart Healthy

Novoste Beta-Cath System

Animal Sources

Letter to Manufacturers of FDA Regulated Medical Devices Containing Animal Tissue Products or Components

Medical Devices Containing Materials Derived from Animal Sources (Except In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry; Final

Annual Reports

CDRH Ombudsman Annual Report for 2001

CDRH Ombudsman Annual Report for 2003

FDA/CDRH Annual Report Fiscal Year 1997

FDA/CDRH Annual Report Fiscal Year 1998

FDA/CDRH Annual Report Fiscal Year 1999

FDA/CDRH Annual Report Fiscal Year 2000

FDA/CDRH Annual Report Fiscal Year 2003

FDA/CDRH Annual Report Highlights for Fiscal Year 1996

Fourth Annual Report of the Medical Devices Annex to the U.S. / EC Mutual Recognition Agreement (MRA)

Office of Device Evaluation (ODE) Fiscal Year 1985 Annual Report

Office of Device Evaluation (ODE) Fiscal Year 1986 Annual Report

Office of Device Evaluation (ODE) Fiscal Year 1987 Annual Report

Office of Device Evaluation (ODE) Fiscal Year 1988 Annual Report

Office of Device Evaluation (ODE) Fiscal Year 1989 Annual Report

Office of Device Evaluation (ODE) Fiscal Year 1990 Annual Report

Office of Device Evaluation (ODE) Fiscal Year 1991 Annual Report

Office of Device Evaluation (ODE) Fiscal Year 1993 Annual Report

Office of Device Evaluation (ODE) Fiscal Year 1994 Annual Report

Office of Device Evaluation (ODE) Fiscal Year 1995 Annual Report

Office of Device Evaluation (ODE) Fiscal Year 1996 Annual Report

Office of Device Evaluation (ODE) Fiscal Year 1997 Annual Report

Office of Device Evaluation (ODE) Fiscal Year 1998 Annual Report

Office of Device Evaluation (ODE) Fiscal Year 1999 Annual Report

Office of Device Evaluation (ODE) Fiscal Year 2000 Annual Report

Office of Device Evaluation (ODE) Fiscal Year 2001 Annual Report

Office of Device Evaluation (ODE) Fiscal Year 2002 Annual Report

Office of Device Evaluation (ODE) Fiscal Year 2003 Annual Report

Office of Health and Industry Programs (OHIP) Fiscal Year 2000 Annual Report

Office of Health and Industry Programs (OHIP) Fiscal Year 2001 Annual Report

Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Fiscal Year 2003 Annual Report

Office of Science and Engineering Laboratories (OSEL - Formerly OST) Fiscal Year 2003 Annual Report

Office of Science and Technology (OST) Fiscal Year 1995 Annual Report

Office of Science and Technology (OST) Fiscal Year 1996 Annual Report

Office of Science and Technology (OST) Fiscal Year 1997 Annual Report

Office of Science and Technology (OST) Fiscal Year 1998 Annual Report

Office of Science and Technology (OST) Fiscal Yearl 1999 Annual Report

Office of Science and Technology (OST) Fiscal Yearl 2000 Annual Report

Office of Science and Technology (OST) Fiscal Yearl 2001 Annual Report

Anthrax

Bioterrorism

FDA Clears Lab Culture Test for Anthrax

Anti-theft Systems

Guidance for Industry: Labeling for Electronic Anti-Theft Systems

Antimicrobial

Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDa

FDA Task Force on Antimicrobial Resistance: Key Recommendations and Report - December 2000

Pesticide Regulation Notice 94-4 Interim Measures for the Registration of Antimicrobial Products/Liquid Chemical Germicides with Medical Device Use Claims

Apnea Monitors

FDA Proposes New Guidance for Apnea Monitors

Arrhythmia Detectors

Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm

Arthritis

Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis

Arthroscopes

Draft Guidance for Arthroscope and Accessory 510(k)s

Aspergillus

FDA Clears Rapid Test for Aspergillus Infection

Assays

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

Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan

Asthma

FDA Clears New Breath Test for Monitoring Asthma

Center for Devices and Radiological Health / CDRH

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.

Abbott
	Abbott Consent Decree
	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

Abbreviated 510(k)s
	Invitation to Preparers of Abbreviated 510(k)s for Selected Devices

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

Abdominal Exercise Products
	Consumer Information on Electronic Muscle Stimulators

Ablation Devices
	Clinical Study Designs for Percutaneous Catheter Ablation for Treatment of Atrial Fibrillation - Guidance for Industry and FDA Staff
	Thermal Endometrial Ablation Devices (Submission Guidance for an IDE)

AbTox Plazlyte Sterilization System
	FDA Safety Alert: Warning Regarding the Use of the AbTox Plazlyte Sterilization System

Accredited Persons
	Requests for Inspection by an Accredited Person Under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002 - Draft Gudiance for Industry, FDA Staff, and FDA-Accredited Third-Pa

Acetabular Cup
	Draft Guidance Document for Testing Acetabular Cup Prostheses

Acupuncture
	Needle Status Reclassification

Administration Sets
	Guidance on Premarket Notifications for Intravascular Administration Sets

Adobe Acrobat Reader
	Helpful Tips for CDRH Documents in PDF Format
	Instructions for Downloading Portable Document Format (PDF) Reader

Adverse Reactions
	How to Report Adverse Reactions and other Problems with Products Regulated by FDA

Advertising and Communication
	"Help-Seeking" and Other Disease Awareness Communications by or on behalf of Drug and Device Firms - Draft Guidance for Industry
	Consumer-Directed Broadcast Advertising of Restricted Devices

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

Advisory Committee and Panel Meetings
	Availability of Information Given to Advisory Committee Members in Connection with CDRH Open Public Panel Meetings; Draft Guidance for Industry and FDA Staff
	Brochure: Request for Nominations for Members and Consultants to Serve on FDA's Medical Devices Advisory Committee
	Draft Guidance on Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees
	Guidance on Amended Procedures for Advisory Panel Meetings; Final
	Overview with Links to Upcoming Meetings and Summaries of Recent Meetings

Alarms
	Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm

Amalgams
	Consumer Update: Dental Amalgams
	Extension Comment Period for Dental Amalgam: Request for Information
	Request for Public Comment on Dental Amalgam: Request for Information
	Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling; Draft Guidance for Industry and FDA

Analyte Specific Reagents
	Analyte Specific Reagents; Small Entity Compliance Guidance; Guidance for Industry

Anesthesia Apparatus
	Anesthesia Apparatus Checkout Recommendations

Aneurysm Clips
	Guidance for Testing MR Interaction with Aneurysm Clips

Aneurysm Repair Devices
	Frequently Asked Questions About Problems With Endovascular Grafts for Treatment of Aortic Abdominal Aneurysms (AAA)

Angioplasty
	Cordis Checkmate System
	How to Keep Your Heart Healthy
	Novoste Beta-Cath System

Animal Sources
	Letter to Manufacturers of FDA Regulated Medical Devices Containing Animal Tissue Products or Components
	Medical Devices Containing Materials Derived from Animal Sources (Except In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry; Final

Annual Reports
	CDRH Ombudsman Annual Report for 2001
	CDRH Ombudsman Annual Report for 2003
	FDA/CDRH Annual Report Fiscal Year 1997
	FDA/CDRH Annual Report Fiscal Year 1998
	FDA/CDRH Annual Report Fiscal Year 1999
	FDA/CDRH Annual Report Fiscal Year 2000
	FDA/CDRH Annual Report Fiscal Year 2003
	FDA/CDRH Annual Report Highlights for Fiscal Year 1996
	Fourth Annual Report of the Medical Devices Annex to the U.S. / EC Mutual Recognition Agreement (MRA)
	Office of Device Evaluation (ODE) Fiscal Year 1985 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1986 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1987 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1988 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1989 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1990 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1991 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1993 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1994 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1995 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1996 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1997 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1998 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 1999 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 2000 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 2001 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 2002 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 2003 Annual Report
	Office of Health and Industry Programs (OHIP) Fiscal Year 2000 Annual Report
	Office of Health and Industry Programs (OHIP) Fiscal Year 2001 Annual Report
	Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Fiscal Year 2003 Annual Report
	Office of Science and Engineering Laboratories (OSEL - Formerly OST) Fiscal Year 2003 Annual Report
	Office of Science and Technology (OST) Fiscal Year 1995 Annual Report
	Office of Science and Technology (OST) Fiscal Year 1996 Annual Report
	Office of Science and Technology (OST) Fiscal Year 1997 Annual Report
	Office of Science and Technology (OST) Fiscal Year 1998 Annual Report
	Office of Science and Technology (OST) Fiscal Yearl 1999 Annual Report
	Office of Science and Technology (OST) Fiscal Yearl 2000 Annual Report
	Office of Science and Technology (OST) Fiscal Yearl 2001 Annual Report

Anthrax
	Bioterrorism
	FDA Clears Lab Culture Test for Anthrax

Anti-theft Systems
	Guidance for Industry: Labeling for Electronic Anti-Theft Systems

Antimicrobial
	Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDa
	FDA Task Force on Antimicrobial Resistance: Key Recommendations and Report - December 2000
	Pesticide Regulation Notice 94-4 Interim Measures for the Registration of Antimicrobial Products/Liquid Chemical Germicides with Medical Device Use Claims

Apnea Monitors
	FDA Proposes New Guidance for Apnea Monitors

Arrhythmia Detectors
	Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm

Arthritis
	Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis

Arthroscopes
	Draft Guidance for Arthroscope and Accessory 510(k)s

Aspergillus
	FDA Clears Rapid Test for Aspergillus Infection

Assays
	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
	Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan

Asthma
	FDA Clears New Breath Test for Monitoring Asthma