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* Draft Guidance for the Content of Premarket Notifications for Menstrual Tampons   [PDF]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

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