FDA Home Page | CDRH Home Page | Search | A-Z Index

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.
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
	Cardiac Ablation Catheters Generic Arrhythmia Indications for Use; Guidance for Industry
	Clinical Study Designs for Percutaneous Catheter Ablation for Treatment of Atrial Fibrillation - Guidance for Industry and FDA Staff
	FDA Public Health Notification: Radiofrequency Ablation of Lung Tumors - Clarification of Regulatory Status
	Investigational Device Exemption (IDE) Study Enrollment for Cardiac Ablation of Typical Atrial Flutter; Final Guidance for Industry and FDA Reviewers
	Recommended Clinical Study Design for Ventricular Tachycardia Ablation
	Thermal Endometrial Ablation Devices (Submission Guidance for an IDE)
Accredited Persons
	Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria: Guidance for Industry, FDA Staff, and Third Parties
	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 - Gudiance for Industry, FDA Staff, and FDA-Accredited Third-Parties
Acupuncture
	Needle Status Reclassification
Addresses
	Addresses for Submissions
Adobe Acrobat Reader
	Helpful Tips for CDRH Documents in PDF Format
	Instructions for Downloading Portable Document Format (PDF) Reader
Adverse Reactions
	Handling Adverse Event Reports
	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
	Immunology Devices Panel, November 16, 2006 Meeting - Slides
	Overview with Links to Upcoming Meetings and Summaries of Recent Meetings
	Pediatric Expertise for Advisory Panels; Guidance for Industry and FDA Staff
Airway
	Class II Special Control Guidance Document for Acute Upper Airway Obstruction Devices; Final
Alarms
	Alarming Monitor Error
	Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm); Final
	Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm
	Sounding the Alarm for I.V. Infiltration
Alpha-Fetoprotein
	Review Criteria for Assessment of Alpha-Fetoprotein (AFP) in vitro Diagnostic Devices for Fetal Open Neural Tube Defects Using Immunological Test Methodologies
Amalgams
	Extension Comment Period for Dental Amalgam: Request for Information
	Questions and Answers on Dental Amalgam
	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
	Guidance for Industry and FDA Staff Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
Analyzer Systems
	Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA
	Review Criteria for Assessment of Cytogenetic Analysis Using Automated and Semi-Automated Chromosome Analyzers
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
	CDRH Ombudsman Annual Report for 2005
	CDRH Ombudsman Annual Report for 2006
	Draft Guidance for Industry and FDA Staff - Annual Reports for Approved Premarket Approval Applications (PMA)
	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 Fiscal Year 2004
	FDA/CDRH Annual Report Fiscal Year 2005
	FDA/CDRH Annual Report Fiscal Year 2006
	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 Communication, Education, and Radiation Programs (OCER) (Formerly Office of Health and Industry Programs (OHIP)) 2005 Annual Report
	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 Device Evaluation (ODE) Fiscal Year 2004 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 2005 Annual Report
	Office of Device Evaluation (ODE) Fiscal Year 2006 and Fiscal Year 2007 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 Health and Industry Programs (OHIP) Fiscal Year 2003 Annual Report
	Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Fiscal Year 2003 Annual Report
	Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Fiscal Year 2005 Annual Report
	Office of Science and Engineering Laboratories (OSEL - Formerly OST) Fiscal Year 2003 Annual Report
	Office of Science and Engineering Laboratories (OSEL) Fiscal Year 2004 Annual Report
	Office of Science and Engineering Laboratories (OSEL) Fiscal Year 2005 Annual Report
	Office of Science and Engineering Laboratories (OSEL) Fiscal Year 2007 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
Annuloplasty
	Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and FDA Staff
Anthrax
	Bioterrorism
	FDA Clears Lab Culture Test for Anthrax
Anti-nuclear Antibodies (ANA)
	Review Criteria for the Assessment of Anti-nuclear Antibodies (ANA) In-Vitro Diagnostic Devices Using Indirect Immunofluorescence Assay (IFA), Immunodiffusion (IMD) and Enzyme Linked Immunosorbant Assay (ELISA)
Anti-saccharomyces cerevisiae
	Class II Special Control Guidance Document for Anti-Saccharomyces cerevisia (S. cerevisiae) Antibody (ASCA) Premarket Notifications
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
	Review Criteria for Assessment of Antimicrobial Susceptibility Test Discs
Apnea Monitors
	Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA
	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
Artificial Discs
	Guidance for Industry and FDA Staff: Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs
Aspergillus
	FDA Clears Rapid Test for Aspergillus Infection
Assays
	Draft Guidance for Industry and FDA Staff: Assay Migration Studies for In Vitro Diagnostic Devices
	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
Atrial Flutter
	Investigational Device Exemption (IDE) Study Enrollment for Cardiac Ablation of Typical Atrial Flutter; Final Guidance for Industry and FDA Reviewers

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH