| A |
| Accelerators |
Office of Device Evaluation, ODE |
|
| Accredited Persons Programs |
Division of Small Manufacturers Assistance, OHIP |
|
| Acoustics - 510(k) |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Acoustics - Compliance |
Division of Enforcement III, OC |
|
| Acupuncture |
Division of Enforcement II, OC |
|
| Acupuncture - Device Evaluation |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Ad Hoc |
Issues Management Staff, OSB |
|
| Adhesive - Bandaids |
Division of General, Restorative and Neurological Devices, ODE |
|
| Adhesive - Tissue |
Division of General, Restorative and Neurological Devices, ODE |
|
| ADP in CDRH |
Issues Management Staff, OSB |
|
| Adverse Events Reports - Database Information |
Information Analysis Branch, OSB |
|
| Adverse Events Reports - Specific Devices |
Division of Postmarket Surveillance, OSB |
|
| Advertising |
Promotion and Advertising Policy Staff, OC |
|
| Advertising on the Internet |
Promotion and Advertising Policy Staff, OC |
|
| Advisory Committees - General |
Office of Systems and Management, OSM |
|
| Advisory Committees - NMQAAC |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Advisory Committees - TEPRSSC |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Advisory-Committees - Device Panels |
Office of the Director, ODE |
|
| Air Cleaners - OC Contact |
Division of Enforcement II, OC |
|
| Air Cleaners - ODE Contact |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Allergy Test |
Division of Clinical and Laboratory Devices, ODE |
|
| Alpha-Fetoprotein (AFP) |
Division of Clinical and Laboratory Devices, ODE |
|
| Analyte Specific Reagents |
Division of Clinical and Laboratory Devices, ODE |
|
| Anesthesia Checklist |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Anesthesiology |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Aneurysm Clips |
Division of General, Restorative and Neurological Devices, ODE |
|
| Aneurysm Clips - Compliance Issues |
Division of Enforcement III, OC |
|
| Angel Wings |
Division of Cardiovascular Devices, ODE |
|
| Angioplasty Devices |
Division of Cardiovascular Devices, ODE |
|
| Angioplasty Devices - Compliance Issues |
Division of Enforcement III, OC |
|
| Annual Report - Center |
Office of the Director, CDRH, OCD |
|
| Annual Report - OC |
Office of the Director, OC |
|
| Annual Report - ODE |
Office of the Director, ODE |
|
| Annual Report - OHIP |
Office of the Director, OHIP |
|
| Annual Report - OSB |
Office of the Director, OSB |
|
| Annual Report - OSEL |
Office of the Director, OSEL |
|
| Anti-microbial Susceptibility Testing (AST) |
Division of Clinical and Laboratory Devices, ODE |
|
| Aortic Valves |
Division of Cardiovascular Devices, ODE |
|
| APNEA Detector - Compliance |
Division of Enforcement III, OC |
|
| APNEA Detector - Device Evaluation |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| APNEA Detector - Educational Issues |
Division of Device User Programs and Systems Analysis, OHIP |
|
| APNEA Detector - Scientific or Technical |
Division of Imaging and Applied Mathematics, OSEL |
|
| Arterial Grafts |
Division of Cardiovascular Devices, ODE |
|
| Assistance to Manufactures |
Division of Small Manufacturers Assistance, OHIP |
|
| Assistive Listening Devices |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Audiometer |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Auditory Traniner |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Automated PAP Smear Preparation Devices and Readers |
Division of Clinical and Laboratory Devices, ODE |
|
| B |
| Bacteriology |
Division of Clinical and Laboratory Devices, ODE |
|
| Biocompatibility |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Biofeedback |
Division of General, Restorative and Neurological Devices, ODE |
|
| Biofeedback - Compliance Issues |
Division of Enforcement III, OC |
|
| Bioresearch Monitoring |
Division of Bioresearch Monitoring, OC |
|
| Biostatistics |
Division of Biostatistics, OSB |
|
| Biostimulator, Laser |
Division of Enforcement III, OC |
|
| Biotechnology |
Division of Clinical and Laboratory Devices, ODE |
|
| Blood Glucose |
Division of Clinical and Laboratory Devices, ODE |
|
| Blood Transfusion Devices |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Blood Transfusion Devices - Compliance |
Division of Enforcement II, OC |
|
| Bone Densitometers - Device Evaluation |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Bone Densitometers - Patient Labeling |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Bone Fixation Appliance |
Division of Chemistry and Materials Science, OSEL |
|
| Brachytherapy |
Division of Cardiovascular Devices, ODE |
|
| Brain |
Division of Enforcement III, OC |
|
| Breast Implants |
Division of General, Restorative and Neurological Devices, ODE |
|
| Breast Implants - Consumer Inquiries |
Division of Small Manufacturers Assistance, OHIP |
|
| Breast Implants - Retrospective Registry |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Breathing Circuits - Device Evaluation |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Breathing Circuits - Education Information |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Budget - Appropriations and Formulations |
Division of Planning, Analysis and Finance, OSM |
|
| Budget - CDRH Execution |
Division of Planning, Analysis and Finance, OSM |
|
| C |
| Carbon Fiber Materials used in X-ray Systems |
Division of Imaging and Applied Mathematics, OSEL |
|
| Cardiovascular Devices - Compliance Issues |
Division of Enforcement III, OC |
|
| Case Management |
Division of Enforcement I, OC |
|
| Catheters (Cardiovascular) |
Division of Postmarket Surveillance, OSB |
|
| Catheters (Cardiovascular) |
Division of Cardiovascular Devices, ODE |
|
| Catheters (Cardiovascular) - Compliance Issues |
Division of Enforcement III, OC |
|
| Cathode Ray Tube (CRT) |
Division of Enforcement III, OC |
|
| CDC Activities |
Office of Surveillance and Biometrics, OSB |
|
| Cell Phones - Bio-Effects |
Division of Biology, OSEL |
|
| Cell Phones - Electromagnetic Interference |
Division of Physics, OSEL |
|
| Cell Phones - Specific Absorpiton Rate (SAR) |
Division of Physics, OSEL |
|
| Certificate for Export |
Division of Program Operations, OC |
|
| Chemistry Products |
Division of Clinical and Laboratory Devices, ODE |
|
| Chiropractic Products |
Division of General, Restorative and Neurological Devices, ODE |
|
| Cholesterol Testing |
Division of Clinical and Laboratory Devices, ODE |
|
| Class II - Petitions for Exemptions |
Program Operations Staff, ODE |
|
| Classification ODE Issues |
Program Operations Staff, ODE |
|
| Clinical Laboratory Improvements Amendments (CLIA) |
Office of In Vitro Diagnostic Device Evaluation and Safety, OIVD |
|
| Clinical Trials - Reporting Complaints - Medical Devices |
Division of Bioresearch Monitoring, OC |
|
| Coagulation Testing and Monitors |
Division of Clinical and Laboratory Devices, ODE |
|
| Cochlear Implant |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Collagen |
Division of General, Restorative and Neurological Devices, ODE |
|
| Color Additives - Device Evaluation |
Program Operations Staff, ODE |
|
| Color Additives - Petitions |
Center for Food Safety and Applied Nutrition, Division of Petition Control, FDA |
|
| Compassionate Use |
Program Operations Staff, ODE |
|
| Computer Report Summaries |
Information Analysis Branch, OSB |
|
| Computer Report Summaries - MDR |
Information Analysis Branch, OSB |
|
| Computer Support |
Office of Information Technology CDRH (OITCDRH), FDA |
|
| Computers in Medicine |
Division of Cardiovascular Devices, ODE |
|
| Condoms - 510(k) |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Condoms - AIDS |
Office of the Director, CDRH, OCD |
|
| Condoms - Compliance |
Division of Enforcement II, OC |
|
| Condoms - Consumer Inquiry |
Division of Small Manufacturers Assistance, OHIP |
|
| Conference of Radiation Control Program Directors |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Conference Room Management - 12725 Twinbrook Parkway, Room 100 |
Office of the Director, OSEL |
|
| Conference Room Management - 1350 Piccard 100U, V, X |
Office of the Director, OSB |
|
| Conference Room Management - 1350 Piccard 120S |
Staff College, OHIP |
|
| Conference Room Management - 9200 Corporate Blvd. |
Office of Device Evaluation, ODE |
|
| Conference Room Management - 2094 Oak Grove 30, 82, 311 |
Office of Compliance, OC |
|
| Conference Room Management - 2098 Oak Grove 159 |
Program Management Office, OSM |
|
| Conference Room Management - 2098 Oak Grove 357 |
Program Management Office, OSM |
|
| Conflict of Interest |
Integrity, Committee and Conference Management Staff, OSM |
|
| Congressional Affairs |
Office of the Director, CDRH, OCD |
|
| Consumer Affairs |
Division of Small Manufacturers Assistance, OHIP |
|
| Consumer Product Safety Commission |
CPSC, FDA |
|
| Contracts |
Division of Planning, Analysis and Finance, OSM |
|
| Cordless Telephones |
Division of Enforcement III, OC |
|
| Correspondence (CDRH) |
Executive Secretariat, CDRH, OCD |
|
| Cosmetic Devices |
Division of General, Restorative and Neurological Devices, ODE |
|
| CRS (Congressional Research Service Inquiries) |
Division of Information Dissemination, OSM |
|
| Cryosurgery |
Division of General, Restorative and Neurological Devices, ODE |
|
| CT (Computed Tomography) - Compliance |
Division of Enforcement I, OC |
|
| CT (Computed Tomography) - Device Evaluation |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| CT (Computed Tomography) - Radiation Risk |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| CT (Computed Tomography) - Science, Technical |
Division of Imaging and Applied Mathematics, OSEL |
|
| D |
| Database - Oracle |
Division of Information Technology, OSM |
|
| Database - Web |
Division of Information Technology, OSM |
|
| Defibrilators - Compliance Issues |
Division of Enforcement III, OC |
|
| Defibrillator |
Division of Cardiovascular Devices, ODE |
|
| Defibrillator - Device Evauation |
Division of Cardiovascular Devices, ODE |
|
| Defibrillator - User Problems |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Dental Amalgams |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Device Advice |
Division of Small Manufacturers Assistance, OHIP |
|
| Device Determinations |
Office of the Director, OC |
|
| Device Labeling |
Office of the Director, OC |
|
| Device Labeling - Patient Labeling |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Device Listing |
Office of Compliance, OC |
|
| Device User Interface |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Diabetes (In Vitro Monitoring) |
Division of Clinical and Laboratory Devices, ODE |
|
| Diabetic Devices |
Division of Clinical and Laboratory Devices, ODE |
|
| Diabetic Devices - Compliance Issues |
Division of Enforcement II, OC |
|
| Diagnostic Test |
Division of Clinical and Laboratory Devices, ODE |
|
| Dialyser |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Dialysis - Compliance |
Division of Enforcement II, OC |
|
| Dialysis - Device |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Dialysis - User Problems |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Diathermy |
Division of Physics, OSEL |
|
| Diathermy - Musculoskeletal Therapy Use |
Division of General, Restorative and Neurological Devices, ODE |
|
| Digital Radiology |
Division of Imaging and Applied Mathematics, OSEL |
|
| Digital Radiology - OC |
Division of Enforcement I, OC |
|
| Digital Radiology - ODE Contact |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Digital Radiology - OHIP |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Disinfectants |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Disinfectants - OC |
Division of Enforcement II, OC |
|
| Disposal Device |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Document Control |
Program Operations Staff, ODE |
|
| Drug Abuse Screening - Compliance |
Office of the Director, OC |
|
| Drug Abuse Screening - Device Evaluation |
Division of Clinical and Laboratory Devices, ODE |
|
| Drug Testing |
Division of Clinical and Laboratory Devices, ODE |
|
| Dura Product |
Division of General, Restorative and Neurological Devices, ODE |
|
| E |
| EEO |
Office of the Director, CDRH, OCD |
|
| Electric Company Power Lines |
Division of Physics, OSEL |
|
| Electrical Blankets |
Division of Physics, OSEL |
|
| Electrical Safety |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Electro Convulsive Therapy - Device Evaluation |
Division of General, Restorative and Neurological Devices, ODE |
|
| Electro Convulsive Therapy - Research |
Division of Biology, OSEL |
|
| Electro Optics |
Division of Physics, OSEL |
|
| Electromagnetic Compatibility (EMC) |
Division of Physics, OSEL |
|
| Electromagnetic Interference (EMI) |
Office of the Director, OSEL |
|
| Electronic Muscle Stimluator (EMS) - Compliance |
Division of Enforcement III, OC |
|
| Electronic Muscle Stimluator (EMS) - Device Evaluation |
Division of General, Restorative and Neurological Devices, ODE |
|
| Electronic Records and Signatures |
Division of Enforcement III, OC |
|
| Electronic Submissions |
Division of Information Dissemination, OSM |
|
| Electronic Submissions - MDR |
Division of Surveillance Systems, OSB |
|
| Electrostatic Discharge |
Division of Imaging and Applied Mathematics, OSEL |
|
| Endoscopes, Washers - Compliance |
Division of Enforcement II, OC |
|
| Endoscopes, Washers - Device Evaluation |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Endoscopes, Washers - User Problems |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Epidemiology |
Division of Postmarket Surveillance, OSB |
|
| Epilators (hair removal device) - Consumer Contact |
Division of Small Manufacturers Assistance, OHIP |
|
| Epilators (hair removal devices) |
Division of General, Restorative and Neurological Devices, ODE |
|
| Ethics |
Integrity, Committee and Conference Management Staff, OSM |
|
| ETO (Ethylene Oxid) - Device Evaluation |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| ETO (Ethylene Oxide) |
Office of the Director, OSEL |
|
| ETO (Ethylene Oxide) - Compliance |
Division of Enforcement I, OC |
|
| European Union (EU) |
Division of Small Manufacturers Assistance, OHIP |
|
| Evaluation of Automatic Class III Designations (deNovo) |
Promotion and Advertising Policy Staff, OC |
|
| Excimer Lasers (Ophthalmic) - Compliance |
Division of Enforcement II, OC |
|
| Excimer Lasers (Ophthalmic) - Device Evaluation |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Exercise Equipment - Home |
Division of Enforcement III, OC |
|
| Exercise Equipment - Musculoskeletal therapy |
Division of General, Restorative and Neurological Devices, ODE |
|
| Export Issues |
Office of the Director, OC |
|
| Extended Wear Contact Lens |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Extramural Research |
Division of Planning, Analysis and Finance, OSM |
|
| F |
| Facilities |
Division of Management Operations, OSM |
|
| FDA Consumer Assistance |
Division of Small Manufacturers Assistance, OHIP |
|
| Federal Management Financial Integrity Act (FMFIA) |
Integrity, Committee and Conference Management Staff, OSM |
|
| Federal-State Relations |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Flow Cytometer |
Division of Clinical and Laboratory Devices, ODE |
|
| Fluoroscopy - OC Contact |
Division of Enforcement I, OC |
|
| Fluoroscopy - OHIP Contact |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Fluoroscopy - OSEL Contact |
Division of Imaging and Applied Mathematics, OSEL |
|
| Focus Testing |
Division of Device User Programs and Systems Analysis, OHIP |
|
| FOI (Freedom of Information) |
Division of Information Dissemination, OSM |
|
| Food and Drug Administration Modernization Act (FDAMA) |
Office of the Director, OHIP |
|
| Food Irradiation |
Center for Food Safety and Applied Nutrition, Division of Petition Control, FDA |
|
| Foreign Inspections |
Division of Program Operations, OC |
|
| Foreign Liaison |
Division of Small Manufacturers Assistance, OHIP |
|
| FTTA (Federal Technology Transfer Act) |
Office of the Director, CDRH, OCD |
|
| G |
| GAO (General Accounting Office) |
Program Management Office, OSM |
|
| Germicides |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| H |
| Health Professional Organizations |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Hearing Aid Regulations |
Promotion and Advertising Policy Staff, OC |
|
| Hearing Aid Regulations - Device |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Hearing Aid Regulations - Patient Labeling |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Heart Valves |
Division of Cardiovascular Devices, ODE |
|
| Heaters |
Division of Physics, OSEL |
|
| Hematology Products - Processes |
Division of Clinical and Laboratory Devices, ODE |
|
| Hemodialysis - Device Evaluation |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Hemodialysis - User Problems |
Division of Device User Programs and Systems Analysis, OHIP |
|
| High Voltage Tension Lines |
Division of Physics, OSEL |
|
| Hip Replacement |
Division of General, Restorative and Neurological Devices, ODE |
|
| Home Use In-Vitro Devices - Guidance |
Division of Clinical and Laboratory Devices, ODE |
|
| Home Use In-Vitro Devices - Issues |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Home Use In-Vitro Devices - Labeling |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Hospital Beds and Cribs |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Hospital Beds and Cribs |
Division of Chemistry and Materials Science, OSEL |
|
| Hospital Beds and Cribs |
Division of Postmarket Surveillance, OSB |
|
| Hospital Beds and Cribs - Compliance |
Division of Enforcement II, OC |
|
| Human Factors Engineering |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Human Tissue |
Division of General, Restorative and Neurological Devices, ODE |
|
| Human Tissue Products |
Division of General, Restorative and Neurological Devices, ODE |
|
| Humanitarian Device Exemption |
Program Operations Staff, ODE |
|
| Hyperbaric Chambers |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Hyperhtermia - Device Evaluation |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| I |
| Imaging Remote (Teleradiology) |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Immunology (Products - Processes) |
Division of Clinical and Laboratory Devices, ODE |
|
| Imports |
Division of Program Operations, OC |
|
| In Vitro Diagnostics - Compliance |
Division of Enforcement I, OC |
|
| In-Vitro Diagnostic Devices - Regulatory Guides and Labeling |
Division of Clinical and Laboratory Devices, ODE |
|
| In-Vitro Diagnostics |
Division of Clinical and Laboratory Devices, ODE |
|
| Incubators - Compliance |
Division of Enforcement II, OC |
|
| Incubators - Device Evaluation |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Infant Monitors |
Division of Enforcement III, OC |
|
| Infection Control - Device Evaluation |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Infection Control - Education |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Infection Control - Mammography |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Infrared |
Division of General, Restorative and Neurological Devices, ODE |
|
| Infusion Pumps |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Infusion Pumps - Compliance |
Division of Enforcement II, OC |
|
| Inhalers |
Division of Cardiovascular Devices, ODE |
|
| Inspector General Inquiries |
Office of the Director, CDRH, OCD |
|
| Insulin Pumps |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Insulin Pumps - Compliance |
Division of Enforcement II, OC |
|
| Integrity |
Division of Integrity, Committee and Conference Management, OSM |
|
| International Affairs |
Division of Small Manufacturers Assistance, OHIP |
|
| Internet Advertising |
Promotion and Advertising Policy Staff, OC |
|
| Internet CDRH Website |
Division of Information Dissemination, OSM |
|
| Intracerebral, Subcortical Stimulator (pain relief) |
Division of General, Restorative and Neurological Devices, ODE |
|
| Intraocular Lens |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Intravenous Tubing |
Division of Surveillance Systems, OSB |
|
| Investigational Device Exemption (IDE) |
Investigational Device Exemptions Staff, Program Operations Staff, ODE |
|
| Iodine-123 |
Office of the Director, OHIP |
|
| IRB (Institutional Review Board) |
Division of Bioresearch Monitoring, OC |
|
| IRB (Institutional Review Board) |
Investigational Device Exemptions Staff, Program Operations Staff, ODE |
|
| J |
| Joints |
Division of Cardiovascular Devices, ODE |
|
| L |
| Labeling - Development |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Labeling - General Medical Devices |
Office of the Director, OC |
|
| Labeling - General Medical Devices |
Division of Small Manufacturers Assistance, OHIP |
|
| Labeling - Home Use Devices |
Office of the Director, OHIP |
|
| Labeling - Home Use Devices |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Labeling - In-Vitro Diagnostics |
Division of Enforcement I, OC |
|
| Labeling - Industry Assistance |
Division of Small Manufacturers Assistance, OHIP |
|
| Labeling - Patient |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Laser (Medical) - Consumer Assistance |
Division of Small Manufacturers Assistance, OHIP |
|
| Laser - Bioeffects |
Division of Biology, OSEL |
|
| Laser - Device Evaluation |
Division of General, Restorative and Neurological Devices, ODE |
|
| Laser - General, Light Shows |
Division of Enforcement III, OC |
|
| Laser, YAG - Compliance |
Division of Enforcement I, OC |
|
| Laser, YAG - Device Evaluation |
Division of General, Restorative and Neurological Devices, ODE |
|
| LASIK |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Latex - Allergy |
Division of Biology, OSEL |
|
| Latex - Chemistry |
Division of Chemistry and Materials Science, OSEL |
|
| Latex - Compliance |
Division of Enforcement I, OC |
|
| Latex - Compliance |
Division of Enforcement II, OC |
|
| Latex - Industry Guidance |
Division of Small Manufacturers Assistance, OHIP |
|
| Latex - Labeling |
Division of Enforcement II, OC |
|
| Learning Laboratory |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Library - Corporate |
Division of Information Dissemination, OSM |
|
| Light Radiation (ultraviolet / sunlamp) - Compliance |
Division of Enforcement III, OC |
|
| Light Radiation (ultraviolet / sunlamp) - Eye |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Light Radiation (ultraviolet / sunlamp) - Skin |
Division of Biology, OSEL |
|
| Liposuction |
Division of General, Restorative and Neurological Devices, ODE |
|
| Lithotripter |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| M |
| Magnetic Resonance Imaging (MRI) |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Magnets |
Office of Compliance, OC |
|
| Magnets - Compliance Issues |
Division of Enforcement III, OC |
|
| Mammography |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Mammography - Device Evaluation |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Manufacturers and User Device Experience (MAUDE) |
Office of Surveillance and Biometrics, OSB |
|
| Manufacturers Assistance |
Division of Small Manufacturers Assistance, OHIP |
|
301-443-6597 / 1-800-638-2041
|
|
|
|
| Materials |
Division of Chemistry and Materials Science, OSEL |
|
| Medical Device Reporting (MDR) - Interpretation of Regulation |
Reporting Systems Monitoring Branch - OSB |
|
| Medical Device Reporting (MDR) - Requirements for Reporting |
Reporting Systems Monitoring Branch - OSB |
|
| Medical Device Reporting (MDR) - Requirements for Reporting |
Reporting Systems Monitoring Branch - OSB |
|
| Medical Device Reporting MDR - General Program |
Office of the Director, OSB |
|
| Medical Physics |
Division of Imaging and Applied Mathematics, OSEL, FDA |
|
| Medical Physics - Device Evaluation |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| MedWatch |
CDER |
|
| Mercury Vapor Lamps |
Division of Enforcement III, OC |
|
| Microbiology |
Division of Clinical and Laboratory Devices, ODE |
|
| Microwave Transmitters |
Division of Physics, OSEL |
|
| Microwaves (Bioeffects) |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Molecular Oncology and Diagnostics |
Division of Clinical and Laboratory Devices, ODE |
|
| Monoclonal Antibodies |
Division of Clinical and Laboratory Devices, ODE |
|
| Muscle Stimulator |
Division of General, Restorative and Neurological Devices, ODE |
|
| Muscle Stimulator -Compliance |
Division of Enforcement III, OC |
|
| Mutual Recognition Agreement (MRA) |
Division of Clinical and Laboratory Devices, ODE |
|
| N |
| Nationwide Evaluation of X-ray Trends (NEXT) |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Naturally Occuring and Accelerator Produced Radioactive Material(NARM) |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Neonatal (In Vitro Testing) |
Division of Clinical and Laboratory Devices, ODE |
|
| Nerve Stimulators |
Division of General, Restorative and Neurological Devices, ODE |
|
| Nerve Stimulators - Compliance Issues |
Division of Enforcement III, OC |
|
| Neurological Catheters |
Division of General, Restorative and Neurological Devices, ODE |
|
| Neurological Devices |
Division of General, Restorative and Neurological Devices, ODE |
|
| Neurological Devices - Compliance Issues |
Division of Enforcement III, OC |
|
| Neurological Embolization |
Division of General, Restorative and Neurological Devices, ODE |
|
| Nuclear Magnetic Resonance Imaging - Compliance |
Division of Enforcement I, OC |
|
| Nuclear Magnetic Resonance Imaging - Device Evaluation |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Nuclear Magnetic Resonance Imaging - Radiation Risk |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Nuclear Medicine - Device Evaluation |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Nuclear Medicine - Medical Associations |
Office of the Director, OHIP |
|
| Nuclear Medicine - Radiation Risk |
Office of the Director, OHIP |
|
| Nuclear Medicine - Therapy |
Division of Biology, OSEL |
|
| O |
| Obstetrics |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Occupational Health and Safety |
Division of Management Operations, OSM |
|
| Office of Public Affairs Contacts |
Broadcast Media |
|
| Office of Public Affairs Contacts |
Print Media |
|
| Ophthalmic Devices |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Ophthalmic Devices - Compliance |
Division of Enforcement II, OC |
|
| Optic Fabrication |
Division of Physics, OSEL |
|
| Optical Radiation (sunlamps, suntan booth) |
Division of Enforcement III, OC |
|
| Optical Radiation (sunlamps, suntan booth) - Eye |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Optical Radiation (sunlamps, suntan booth) - skin |
Division of Biology, OSEL |
|
| Orphan Devices |
Program Operations Staff, ODE |
|
| Orthopedics |
Division of General, Restorative and Neurological Devices, ODE |
|
| Orthopedics - Compliance |
Division of Enforcement II, OC |
|
| Osteoporesis Testing |
Division of Clinical and Laboratory Devices, ODE |
|
| Over the Counter In Vitro Devices |
Division of Clinical and Laboratory Devices, ODE |
|
| Oxygen Generators |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Ozone Generators |
Division of Enforcement II, OC |
|
| P |
| Pacemakers - Compliance Issues |
Division of Enforcement III, OC |
|
| Pacemakers - Devices |
Division of Cardiovascular Devices, ODE |
|
| Pacemakers - Implant Letters |
Health Care Financing Administration, FDA |
|
| Pacemakers - Postmarket |
Division of Postmarket Surveillance, OSB |
|
| Pain Relief Devices |
Division of General, Restorative and Neurological Devices, ODE |
|
| Pain Relief Devices - Compliance Issues |
Division of Enforcement III, OC |
|
| Panel Meetings |
Office of the Director, ODE |
|
| PAP Smear Preparation Devices and Readers |
Division of Clinical and Laboratory Devices, ODE |
|
| Paperwork Reduction Act |
Division of Management Operations, OSM |
|
| Parasitology |
Division of Clinical and Laboratory Devices, ODE |
|
| Part 11 Electronic Records and Signatures |
Division of Enforcement III, OC |
|
| Patents |
Regulations Staff, OHIP |
|
| Pathology |
Division of Clinical and Laboratory Devices, ODE |
|
| Pathology - Compliance |
Division of Enforcement I, OC |
|
| Patient (lay) Use |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Patient Cables and Lead Wires |
Division of Enforcement III, OC |
|
| Patient Labeling |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Patient Restraints |
Division of Enforcement II, OC |
|
| Personnel - Civil Service |
Division of Management Operations, OSM |
|
| Personnel - Commissioned Corps |
CDRH Commissioned Corps Liaison, OCD |
|
| Physical Medicine Products |
Division of General, Restorative and Neurological Devices, ODE |
|
| Physical Medicine Products - Compliance |
Division of Enforcement I, OC |
|
| Physical Therpay |
Division of General, Restorative and Neurological Devices, ODE |
|
| Picture Archiving Communications System - Device Evaluation |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Plastic Surgery |
Division of General, Restorative and Neurological Devices, ODE |
|
| Point of Care In Vitro Testing |
Division of Clinical and Laboratory Devices, ODE |
|
| Positron Emission Tomography (PET) Scan - Device Issues |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Positron Emission Transaxial Tomography ( PET Scan) - Compliance |
Division of Enforcement I, OC |
|
| Positron Emission Transaxial Tomography ( PET Scan) Clinical |
Office of the Director, OHIP |
|
| Postmarket Surveillance Studies |
Issues Management Staff, OSB |
|
| Power Lines (Outdoor) |
Division of Physics, OSEL |
|
| Power Lines (Outdoor) |
Division of Biology, OSEL |
|
| Pregnancy Test Kits |
Division of Clinical and Laboratory Devices, ODE |
|
| Pregnancy Test Kits - Compliance |
Division of Enforcement I, OC |
|
| Premarket Approval (PMA) |
Premarket Approval Staff, ODE |
|
| Premarket Notification (510(k)) |
Program Operations Staff, ODE |
|
| Promotion Labeling |
Promotion and Advertising Policy Staff, OC |
|
| Prosthetic Devices |
Division of General, Restorative and Neurological Devices, ODE |
|
| PSA Testing |
Division of Clinical and Laboratory Devices, ODE |
|
| Public Health Advisories |
Issues Management Staff, OSB |
|
| Publications |
Division of Small Manufacturers Assistance, OHIP |
|
301-443-6597 / 1-800-638-2041
|
|
|
|
| PUVA (Psoriasis Phototheraphy) |
Division of General, Restorative and Neurological Devices, ODE |
|
| Q |
| Quackery (Health Fraud) |
Division of Enforcement I, OC |
|
| Qualitative Research |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Quality Assurance |
Division of Enforcement III, OC |
|
| Quality Assurance - Diagnostic Radiology |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Quality Assurance - Mammography |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Quality Systems |
Division of Small Manufacturers Assistance, OHIP |
|
| Qualtiy Assurance - Technique Exposure Guides |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| R |
| Radiation Emergency Planning and Response |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Radiation Monitoring (PHS Personnel) |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Radiation Safety Officer for CDRH |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Radiation Therapy |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Radiation Therapy |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Radiation Therapy |
Division of Biology, OSEL |
|
| Radiation, Broadcast Station |
Environmental Protection Agency, FDA |
|
| Radio Frequency (RF) Heaters |
Division of Biology, OSEL |
|
| Radio Frequency (RF) Heaters |
Division of Physics, OSEL |
|
| Radio Frequency Sealers |
Division of Physics, OSEL |
|
| Radio Frequency Sealers |
Division of Biology, OSEL |
|
| Radioactive Consumer Products ( Dishes, jewelry, watches) |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Radiology Clinical |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Radiology Imaging |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Radiology Imaging |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Radiology Imaging |
Division of Enforcement I, OC |
|
| Radiology Imaging |
Office of Surveillance and Biometrics, OSB |
|
| Radiology Imaging |
Division of Imaging and Applied Mathematics, OSEL, FDA |
|
| Radiopharmaceuticals |
Office of the Director, OHIP |
|
| Recalls Notification - OC |
Division of Enforcement I, OC |
|
| Recalls Notification - Patient Notification |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Reclassification - FR Notices |
Regulations Staff, OHIP |
|
| Reclassification - ODE |
Program Operations Staff, ODE |
|
| Registration and Listing |
Division of Program Operations, OC |
|
| Regulatory Guidance |
Division of Small Manufacturers Assistance, OHIP |
|
301-443-6597 / 1-800-638-2041
|
|
|
|
| Rehabilitation Devices |
Division of General, Restorative and Neurological Devices, ODE |
|
| Replacement Reagents |
Division of Clinical and Laboratory Devices, ODE |
|
| Request for Classification Information 513(g) |
Program Operations Staff, ODE |
|
| Risk Analysis and Management - User Error |
Division of Device User Programs and Systems Analysis, OHIP |
|
| S |
| Safe Medical Device Act (SMDA) |
Regulations Staff, OHIP |
|
| Safety Alerts |
Issues Management Staff, OSB |
|
| Sharps Containers |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Sharps Containers |
Division of Enforcement II, OC |
|
| Silicone |
Division of General, Restorative and Neurological Devices, ODE |
|
| Silicone - Consumer Information |
Division of Small Manufacturers Assistance, OHIP |
|
| Smoke Detector |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Snoring Devices |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| Snoring Devices (jaw positioning) |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Software and Computerized Medical Devices |
Division of Cardiovascular Devices, ODE |
|
| Software and Computerized Medical Devices |
Division of Enforcement III, OC |
|
| Software and Computerized Medical Devices |
Regulations Staff, OHIP |
|
| Software and Computerized Medical Devices |
Division of Imaging and Applied Mathematics, OSEL, FDA |
|
| SPECT Scan |
Division of Enforcement I, OC |
|
| SPECT Scan |
Office of the Director, OHIP |
|
| SPECT Scan |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Staff College |
Staff College, OHIP |
|
| State Medical Device and Radiological Health Activities |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Statistics/Statistical Analysis |
Division of Biostatistics, OSB |
|
| Sterilants, Liquid and Germicides |
Division of Enforcement II, OC |
|
| Sterilization |
Division of Enforcement I, OC |
|
| Sterilization |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Sterilizers |
Division of Enforcement II, OC |
|
| Stimulator |
Division of General, Restorative and Neurological Devices, ODE |
|
| Strategic Plan |
Office of the Director, CDRH, OCD |
|
| Sunglasses |
Division of Enforcement III, OC |
|
| Sunglasses |
Division of Small Manufacturers Assistance, OHIP |
|
| Suntanning Devices - Compliance |
Division of Enforcement III, OC |
|
| Suntanning Devices - Consumer Assistance |
Division of Small Manufacturers Assistance, OHIP |
|
| Suntanning Devices - OC Rad Health |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Suntanning Devices - Skin |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Suntanning Devices - Skin |
Division of Biology, OSEL |
|
| Surgical |
Division of Enforcement I, OC |
|
| Surgical |
Division of General, Restorative and Neurological Devices, ODE |
|
| Sutures |
Division of General, Restorative and Neurological Devices, ODE |
|
| Sutures |
Division of Enforcement I, OC |
|
| Syringes - Compliance |
Division of Enforcement II, OC |
|
| Syringes - Device Evaluation |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Systematic Technology Assessment for Medical Products ( STAMP) |
Issues Management Staff, OSB |
|
| T |
| Tamper Resistant Packages |
Regulations Staff, OHIP |
|
| Tanning - Bioeffects |
Division of Biology, OSEL |
|
| Teleconferences |
Division of Communication Media, OHIP |
|
| Teleradiology |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Television |
Division of Enforcement III, OC |
|
| Television Production |
Division of Communication Media, OHIP |
|
| Temporomandibular Joint (TMJ) |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Temporomandibular Joint (TMJ) |
Division of Enforcement II, OC |
|
| Temporomandibular Joint (TMJ) - Consumer Assistance |
Division of Small Manufacturers Assistance, OHIP |
|
| Test Kits |
Division of Clinical and Laboratory Devices, ODE |
|
| Thermograph |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Third Party Accreditation |
Division of Small Manufacturers Assistance, OHIP |
|
| Third Party Reviews of 510(k)s |
Program Operations Staff, ODE |
|
| Time Reporting |
Division of Planning, Analysis and Finance, OSM |
|
| Toxicology |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Toxicology |
Division of Enforcement I, OC |
|
| Toxicology |
Division of Biology, OSEL |
|
| Training |
Staff College, OHIP |
|
| Transcutaneous Electrical Nerve Stimulators (TENS) |
Division of General, Restorative and Neurological Devices, ODE |
|
| Transillumination |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Transillumination |
Division of Enforcement I, OC |
|
| TSS (Toxic Shock Syndrome) |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Tumor Marker Assays |
Division of Clinical and Laboratory Devices, ODE |
|
| U |
| Ultrasound |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Ultrasound |
Division of Enforcement I, OC |
|
| Ultrasound |
Division of Biology, OSEL |
|
| Urology Devices |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| Urology Devices - Compliance Issues |
Division of Enforcement II, OC |
|
| Usability (testing, validation), User error |
Division of Device User Programs and Systems Analysis, OHIP |
|
| Use error |
Division of Device User Programs and Systems Analysis, OHIP |
|
| User Fees, CDRH |
Division of Planning, Analysis and Finance, OSM |
|
| User Fees, CDRH |
Office of the Director, CDRH, OCD |
|
| User Fees, ODE |
Program Operations Staff, ODE |
|
| User Interface |
Division of Device User Programs and Systems Analysis, OHIP |
|
| UV (Ultraviolet Radiation) - Bioeffects |
Division of Biology, OSEL |
|
| UV (Ultraviolet Radiation) - Eye |
Division of Ophthalmic and Ear, Nose and Throat Devices, ODE |
|
| UV (Ultraviolet Radiation) - Skin |
Division of Biology, OSEL |
|
| UV (Ultraviolet Radiation) - State and Local Regulations |
Division of Small Manufacturers Assistance, OHIP |
|
301-443-6597 / 1-800-638-2041
|
|
|
|
| V |
| Ventilators |
Div. of Anesthesiology, Gen. Hosp., Infection Control and Dental Devices, ODE |
|
| Video Conferencing |
Division of Information Dissemination, OSM |
|
| Video Display Terminals (VDT) |
Division of Enforcement III, OC |
|
| Videotape Products |
Division of Communication Media, OHIP |
|
| Virology |
Division of Clinical and Laboratory Devices, ODE |
|
| W |
| Waived Tests for CLIA |
Division of Clinical and Laboratory Devices, ODE |
|
| Website |
Division of Information Dissemination, OSM |
|
| World Health Organization (WHO) |
Division of Small Manufacturers Assistance, OHIP |
|
301-443-6597 / 1-800-638-2041
|
|
|
|
| Wound Dressing - Compliance |
Division of Enforcement I, OC |
|
| Wound Dressings - Devices |
Division of General, Restorative and Neurological Devices, ODE |
|
| X |
| X-ray - Bioeffects |
Division of Biology, OSEL |
|
| X-ray - Compliance Isues |
Division of Enforcement I, OC |
|
| X-ray - Device Issues |
Division of Reproductive, Abdominal and Radiological Devices, ODE |
|
| X-ray - Equipment |
Division of Mammography Quality and Radiation Programs, OHIP |
|
| Y |
| YAG Laser |
Division of Enforcement I, OC |
|
| YAG Laser |
Division of General, Restorative and Neurological Devices, ODE |
|
| Yorick |
Office of the Director, OSEL |
|
