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Index of CDRH Web Documents

KEY: Links are numbered according to what type of file they point to. 1=Text, 2=PDF, 3=PowerPoint, 4=Word, 5=XML, 6=See Also. 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 
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Some additional items of interest can be found on the Consumer Information page.
 
Abbott
* Abbott Consent Decree [Text]
* Abbott Labs Signs Consent Decree with FDA; Agrees to Correct Manufacturing Deficiencies [Text]
* Dear Colleague Letter: Abbott Laboratories Consent Decree [Text] [PDF]
* Q’s and A’s – Abbott’s In Vitro Diagnostic Products [Text] [PDF]
* US District Court for Illinois Order Dated 11/19/1999; Abbott Consent Decree - Amendment of Effective Date   [PDF]
 
Abbreviated 510(k)s
* Invitation to Preparers of Abbreviated 510(k)s for Selected Devices [Text]
 
Abdominal
* Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Guidance for Industry [Text] [PDF]
 
Abdominal Exercise Products
* Consumer Information on Electronic Muscle Stimulators [Text]
 
Ablation Devices
* Cardiac Ablation Catheters Generic Arrhythmia Indications for Use; Guidance for Industry [Text] [PDF]
* Clinical Study Designs for Percutaneous Catheter Ablation for Treatment of Atrial Fibrillation - Guidance for Industry and FDA Staff [Text] [PDF]
* FDA Public Health Notification: Radiofrequency Ablation of Lung Tumors - Clarification of Regulatory Status [Text]
* Investigational Device Exemption (IDE) Study Enrollment for Cardiac Ablation of Typical Atrial Flutter; Final Guidance for Industry and FDA Reviewers [Text] [PDF]
* Recommended Clinical Study Design for Ventricular Tachycardia Ablation [Text] [PDF]
* Thermal Endometrial Ablation Devices (Submission Guidance for an IDE) [Text] [PDF]
 
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 [Text] [PDF]
* 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 [Text] [PDF]
 
Acupuncture
* Needle Status Reclassification [Text]
 
Addresses
* Addresses for Submissions [Text]
 
Adobe Acrobat Reader
* Helpful Tips for CDRH Documents in PDF Format [Text]
* Instructions for Downloading Portable Document Format (PDF) Reader [Text]
 
Adverse Reactions
* Handling Adverse Event Reports   [PDF]
* How to Report Adverse Reactions and other Problems with Products Regulated by FDA [Text]
 
Advertising and Communication
* "Help-Seeking" and Other Disease Awareness Communications by or on behalf of Drug and Device Firms - Draft Guidance for Industry   [PDF]
* Consumer-Directed Broadcast Advertising of Restricted Devices [Text] [PDF]
 
Advice
* Device Advice: the CDRH self-service site for medical device and radiation emitting product information [Text]
 
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 [Text] [PDF]
* Brochure: Request for Nominations for Members and Consultants to Serve on FDA's Medical Devices Advisory Committee [Text] [PDF]
* Draft Guidance on Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees [Text]
* Guidance on Amended Procedures for Advisory Panel Meetings; Final [Text] [PDF]
* Immunology Devices Panel, November 16, 2006 Meeting - Slides [Text]
* Overview with Links to Upcoming Meetings and Summaries of Recent Meetings [Text]
* Pediatric Expertise for Advisory Panels; Guidance for Industry and FDA Staff [Text] [PDF]
 
Airway
* Class II Special Control Guidance Document for Acute Upper Airway Obstruction Devices; Final [Text] [PDF]
 
Alarms
* Alarming Monitor Error [Text] [PDF]
* Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm); Final [Text] [PDF]
* Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm [Text] [PDF]
* Sounding the Alarm for I.V. Infiltration [Text] [PDF]
 
Alpha-Fetoprotein
* Review Criteria for Assessment of Alpha-Fetoprotein (AFP) in vitro Diagnostic Devices for Fetal Open Neural Tube Defects Using Immunological Test Methodologies   [PDF]
 
Amalgams
* Extension Comment Period for Dental Amalgam: Request for Information [Text]
* Questions and Answers on Dental Amalgam [Text]
* Request for Public Comment on Dental Amalgam: Request for Information [Text]
* Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling; Draft Guidance for Industry and FDA [Text] [PDF]
 
Analyte Specific Reagents
* Guidance for Industry and FDA Staff Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions [Text] [PDF]
 
Analyzer Systems
* Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA [Text] [PDF]
* Review Criteria for Assessment of Cytogenetic Analysis Using Automated and Semi-Automated Chromosome Analyzers [Text]
 
Aneurysm Clips
* Guidance for Testing MR Interaction with Aneurysm Clips [Text] [PDF]
 
Aneurysm Repair Devices
* Frequently Asked Questions About Problems With Endovascular Grafts for Treatment of Aortic Abdominal Aneurysms (AAA) [Text]
 
Angioplasty
* Cordis Checkmate System [Text] [PDF]
* How to Keep Your Heart Healthy [Text]
* Novoste Beta-Cath System [Text] [PDF]
 
Animal Sources
* Letter to Manufacturers of FDA Regulated Medical Devices Containing Animal Tissue Products or Components   [PDF]
* Medical Devices Containing Materials Derived from Animal Sources (Except In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry; Final [Text] [PDF]
 
Annual Reports
* CDRH Ombudsman Annual Report for 2001 [Text] [PDF]
* CDRH Ombudsman Annual Report for 2003 [Text]
* CDRH Ombudsman Annual Report for 2005 [Text]
* CDRH Ombudsman Annual Report for 2006 [Text]
* Draft Guidance for Industry and FDA Staff - Annual Reports for Approved Premarket Approval Applications (PMA) [Text] [PDF]
* FDA/CDRH Annual Report Fiscal Year 1997 [Text]
* FDA/CDRH Annual Report Fiscal Year 1998 [Text] [PDF]
* FDA/CDRH Annual Report Fiscal Year 1999 [Text] [PDF]
* FDA/CDRH Annual Report Fiscal Year 2000 [Text] [PDF]
* FDA/CDRH Annual Report Fiscal Year 2003 [Text] [PDF]
* FDA/CDRH Annual Report Fiscal Year 2004 [Text] [PDF]
* FDA/CDRH Annual Report Fiscal Year 2005 [Text] [PDF]
* FDA/CDRH Annual Report Fiscal Year 2006 [Text] [PDF]
* FDA/CDRH Annual Report Highlights for Fiscal Year 1996 [Text]
* Fourth Annual Report of the Medical Devices Annex to the U.S. / EC Mutual Recognition Agreement (MRA) [Text]
* Office of Communication, Education, and Radiation Programs (OCER) (Formerly Office of Health and Industry Programs (OHIP)) 2005 Annual Report [Text] [PDF]
* Office of Device Evaluation (ODE) Fiscal Year 1985 Annual Report   [PDF]
* Office of Device Evaluation (ODE) Fiscal Year 1986 Annual Report   [PDF]
* Office of Device Evaluation (ODE) Fiscal Year 1987 Annual Report   [PDF]
* Office of Device Evaluation (ODE) Fiscal Year 1988 Annual Report   [PDF]
* Office of Device Evaluation (ODE) Fiscal Year 1989 Annual Report   [PDF]
* Office of Device Evaluation (ODE) Fiscal Year 1990 Annual Report   [PDF]
* Office of Device Evaluation (ODE) Fiscal Year 1991 Annual Report   [PDF]
* Office of Device Evaluation (ODE) Fiscal Year 1993 Annual Report   [PDF]
* Office of Device Evaluation (ODE) Fiscal Year 1994 Annual Report   [PDF]
* Office of Device Evaluation (ODE) Fiscal Year 1995 Annual Report   [PDF]
* Office of Device Evaluation (ODE) Fiscal Year 1996 Annual Report   [PDF]
* Office of Device Evaluation (ODE) Fiscal Year 1997 Annual Report   [PDF]
* Office of Device Evaluation (ODE) Fiscal Year 1998 Annual Report   [PDF]
* Office of Device Evaluation (ODE) Fiscal Year 1999 Annual Report [Text] [PDF]
* Office of Device Evaluation (ODE) Fiscal Year 2000 Annual Report [Text] [PDF]
* Office of Device Evaluation (ODE) Fiscal Year 2001 Annual Report [Text] [PDF]
* Office of Device Evaluation (ODE) Fiscal Year 2002 Annual Report [Text] [PDF]
* Office of Device Evaluation (ODE) Fiscal Year 2003 Annual Report [Text] [PDF]
* Office of Device Evaluation (ODE) Fiscal Year 2004 Annual Report [Text] [PDF]
* Office of Device Evaluation (ODE) Fiscal Year 2005 Annual Report [Text] [PDF]
* Office of Device Evaluation (ODE) Fiscal Year 2006 and Fiscal Year 2007 Annual Report [Text] [PDF]
* Office of Health and Industry Programs (OHIP) Fiscal Year 2000 Annual Report [Text] [PDF]
* Office of Health and Industry Programs (OHIP) Fiscal Year 2001 Annual Report [Text] [PDF]
* Office of Health and Industry Programs (OHIP) Fiscal Year 2003 Annual Report [Text] [PDF]
* Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Fiscal Year 2003 Annual Report [Text] [PDF]
* Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Fiscal Year 2005 Annual Report [Text] [PDF]
* Office of Science and Engineering Laboratories (OSEL - Formerly OST) Fiscal Year 2003 Annual Report [Text] [PDF]
* Office of Science and Engineering Laboratories (OSEL) Fiscal Year 2004 Annual Report [Text] [PDF]
* Office of Science and Engineering Laboratories (OSEL) Fiscal Year 2005 Annual Report [Text] [PDF]
* Office of Science and Engineering Laboratories (OSEL) Fiscal Year 2007 Annual Report [Text] [PDF]
* Office of Science and Technology (OST) Fiscal Year 1995 Annual Report [Text]
* Office of Science and Technology (OST) Fiscal Year 1996 Annual Report [Text]
* Office of Science and Technology (OST) Fiscal Year 1997 Annual Report [Text]
* Office of Science and Technology (OST) Fiscal Year 1998 Annual Report [Text] [PDF]
* Office of Science and Technology (OST) Fiscal Yearl 1999 Annual Report [Text] [PDF]
* Office of Science and Technology (OST) Fiscal Yearl 2000 Annual Report [Text] [PDF]
* Office of Science and Technology (OST) Fiscal Yearl 2001 Annual Report [Text] [PDF]
 
Annuloplasty
* Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and FDA Staff [Text] [PDF]
 
Anthrax
* Bioterrorism [Text]
* FDA Clears Lab Culture Test for Anthrax [Text]
 
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)   [PDF]
 
Anti-saccharomyces cerevisiae
* Class II Special Control Guidance Document for Anti-Saccharomyces cerevisia (S. cerevisiae) Antibody (ASCA) Premarket Notifications [Text] [PDF]
 
Antimicrobial
* Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA [Text] [PDF]
* FDA Task Force on Antimicrobial Resistance: Key Recommendations and Report - December 2000 [Text]
* Pesticide Regulation Notice 94-4 Interim Measures for the Registration of Antimicrobial Products/Liquid Chemical Germicides with Medical Device Use Claims   [PDF]
* Review Criteria for Assessment of Antimicrobial Susceptibility Test Discs   [PDF]
 
Apnea Monitors
* Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA [Text] [PDF]
* FDA Proposes New Guidance for Apnea Monitors [Text]
 
Arrhythmia Detectors
* Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm [Text] [PDF]
 
Arthritis
* Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis   [PDF] [Word]
 
Artificial Discs
* Guidance for Industry and FDA Staff: Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs [Text] [PDF]
 
Aspergillus
* FDA Clears Rapid Test for Aspergillus Infection [Text]
 
Assays
* Draft Guidance for Industry and FDA Staff: Assay Migration Studies for In Vitro Diagnostic Devices [Text] [PDF]
* Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan [Text] [PDF]
 
Asthma
* FDA Clears New Breath Test for Monitoring Asthma [Text]
 
Atrial Flutter
* Investigational Device Exemption (IDE) Study Enrollment for Cardiac Ablation of Typical Atrial Flutter; Final Guidance for Industry and FDA Reviewers [Text] [PDF]
 

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