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T-Scan 2000 Breast Imaging Device |
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FDA Approves New Breast Imaging Device |
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Tables |
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Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Tables and Multifunctional Physical Therapy Tables |
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Talk Papers |
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Class 1 Exemptions - Low Risk Medical Devices |
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FDA Approves Adhesive for Skin Wound Closure |
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FDA Authorizes Seizure of Unapproved Lasers |
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Tampons |
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Draft Guidance for the Content of Premarket Notifications for Menstrual Tampons |
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FR Notice: Labeling for Menstrual Tampon for the ``Ultra'' Absorbency |
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FR Notice: Labeling for Menstrual Tampons; Ranges of Absorbency, Change From ``Junior'' to ``Light'' |
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Tampons and Asbestos, Dioxin, & Toxic Shock Syndrome |
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Tampons and Toxic Shock Syndrome |
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Tanning |
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Don't Be in the Dark About Tanning |
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Sunscreens, Tanning Products, and Sun Safety |
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The Darker Side of Tanning |
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Technology Transfer |
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FDA Technology Transfer Program |
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Telemedicine |
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Wireless Medical Telemetry - Electromagnetic Interference Concerns and Solutions |
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Wireless Medical Telemetry Risks and Recommendations |
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Television |
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Division of Communication Media |
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Guidance on Electronic Products which Emit Radiation |
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Procedures for Laboratory Compliance Testing of Television Receivers |
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Reporting and Compliance Guide for Television Products including Product Report, Supplemental Report, Radiation Safety Abbreviated Report, Annual Report, Information and Guidance |
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We Want You to Know About Television Radiation |
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Temporomandibular Joint |
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Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices - Guidance for Industry and FDA Staff |
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Temporomandibular Joint - See TMJ |
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Temporomandibular Joint (TMJ) Implants |
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Important Information About TMJ Implants |
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Public Health Need Letter for P990002 - TMJ Implants Inc |
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TMJ Implants - A Consumer Information Update |
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Universe of Devices Used in the Diagnosis and/or Treatment of Temporomandibular Joint Disorders and Related Myofacial Pain Dysfunction |
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TENS |
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Guide for TENS 510(k) Content (Draft) |
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TEPRSSC |
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Technical Electronic Product Radiation Safety Standards Advisory Committee (TEPRSSC) |
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Test Kits |
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FDA Clears New Test for Lyme Disease |
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FDA Proposes New Policy for Home Drug Abuse Test Kits |
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FDA Public Health Advisory: Limitations of Toxoplasma IgM Commercial Test Kits |
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FDA Safety Alert: Risks of Devices for Direct Determination of Group B Streptococcal Antigen |
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Lyme Disease Test Kits: Potential for Misdiagnosis |
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Testicular Prostheses |
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Draft Guidance for Preparation of PMA Applications for Testicular Prostheses |
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Thermal Devices |
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Guidance ('Guidelines') for Evaluation of Laparoscopic Bipolar and Thermal Coagulators (and Accessories) |
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Thermometers |
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Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers |
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Thermotherapy |
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FDA Public Health Notification: Serious Injuries from Microwave Thermotherapy for Benign Prostatic Hyperplasia |
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Third Party Review |
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Guidance for Staff, Industry and Third Parties: Third Party Programs Under the Sectoral Annex on Medical Devices to the Agreement on Mutual Recognition Between the United States of America and the European Community (MRA) |
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Guidance for Staff, Industry, and Third Parties; Implementation of Third Party Programs Under the FDA Modernization Act of 1997-Appendix A |
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Guidance for Staff, Industry, and Third Parties; Implementation of Third Party Programs Under the FDA Modernization Act of 1997-Appendix B |
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Guidance for Third Parties and FDA Staff; Third Party Review of Premarket Notifications |
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Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties |
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Inclusion of Certain Devices Within the Accredited Persons Program - Third Party Review of Clinical Data: A Report to Congress |
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List of Accredited Persons for 510(k) Review under the FDA Modernization Act of 1997 |
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Third Party Review Information |
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Tissue Cultures |
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Class II Special Controls Guidance Document: Tissue Culture Media for Human ex vivo Tissue and Cell Culture Processing Applications; Final Guidance for Industry and FDA Reviewers |
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Tissue Engineering |
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Tissue Engineered Medical Products Standards (TEMPS) Information |
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Tissue Spongiform Encephalopathy (TSE) |
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Letter to Manufacturers of FDA Regulated Medical Devices Containing Animal Tissue Products or Components |
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Tomography |
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Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems; Final |
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Guide for the filing of Annual Reports for X-Ray Components and Systems |
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Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems |
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Nationwide Evaluation of X-ray Trends (NEXT) 2000 Protocol for Survey of Computed Tomography (CT) |
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Toxic Shock |
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Tampons and Asbestos, Dioxin, & Toxic Shock Syndrome |
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Tampons and Toxic Shock Syndrome |
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Tracking |
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Devices Subject to Tracking |
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FR Notice: Medical Devices; Device Tracking; New Orders to Manufacturers |
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Medical Device Tracking |
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Medical Device Tracking - Guidance for Industry and FDA Staff |
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Medical Devices; Device Tracking - Final Rule; FR February 8, 2002 |
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Transducers |
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Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers |
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Transplantation |
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Guidance for Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport, and Storage of Organs for Transplantation; Final Guidance for Industry and FDA Reviewers |
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Trocars |
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Shielded Trocars and Needles Used for Abdominal Access During Laparoscopy |
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Tubal Occlusion Devices |
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Guidance ('Guidelines') for Evaluation of Tubal Occlusion Devices |
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