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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.
 
Facility Locations
* Center for Devices and Radiological Health - Facility Locations - Map [Text]
 
Factor V Leiden
* Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems - Guidance for Industry and FDA Staff [Text] [PDF]
 
Facts-on-Demand
* Facts On Demand Overview [Text]
 
Falloposcopes
* Letter to Manufacturers of Falloposcopes [Text] [PDF]
* Premarket Testing Guidelines for Falloposcopes   [PDF]
 
FDA & YOU
* FDA & YOU - News for Health Educators and Students [Text]
 
FDA (Food and Drug Administration)
* A Tour of the FDA [Text]
* FDA Advisory Committes in CDRH [Text]
* FDA Home Page [Text]
* FDA Performance Plan FY2002 - Medical Devices and Radiological Health [Text]
* Report on FDA Plan for Statutory Compliance [Text]
 
FDA Consumer Magazine
* FDA Consumer Magazine [Text]
 
FDAMA
* Draft Guidance on Evidence Models for the Least Burdensome Means to Market [Text] [PDF]
* Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff [Text] [PDF]
* Medical Devices; Exemption From Premarket Notification and Reserved Devices; Class 1 [Text] [PDF]
* Presentation: The Least Burdensome Provisions of the FDA Modernization Act of 1997   [PDF] [PowerPoint PPT]
* Report on FDA Plan for Statutory Compliance [Text]
 
Fecal
* Fecal Occult Blood Home Use Test [Text]
 
Federal Register Notices
* Federal Register Online at GPO [Text]
 
Fellowship Program
* Medical Device Fellowship Program [Text]
 
Female Sexual Therapy Devices
* FDA Clears New Female Sexual Therapy Device [Text]
 
Femoral Stem
* Draft Guidance Document for Femoral Stem Prostheses [Text] [PDF]
 
Fetal
* Consumer Update on Fetal Keepsake Videos [Text]
* FDA Cautions Against Ultrasound 'Keepsake' Images [Text]
* Guidance ('Guidelines') for Evaluation of Fetal Clip Electrode   [PDF]
 
Fetal Keepsake Videos
* Consumer Update on Fetal Keepsake Videos [Text]
* FDA Cautions Against Ultrasound 'Keepsake' Images [Text] [Text]
 
Fetal Oxygen
* FDA Approves New Fetal Oxygen Saturation Monitor [Text]
* Summary Information on OxiFirst™Fetal Oxygen Saturation Monitoring System - P990053 [Text]
 
Fetal Stents
* Fetal Stent Receives First"Humanitarian Use Approval [Text]
 
Fibroids
* FDA Clears Device to Treat Fibroids [Text]
 
Financial Disclosure
* Financial Interest Form: Certification: Financial Interests and Arrangements of Clinical Investigations FDA Form 3454   [PDF]
* Financial Interest Forms: Disclosure: Financial Interests and Arrangements of Clinical Investigators FDA Form 3455   [PDF]
* Guidance for Industry: Financial Disclosure by Clinical Investigators [Text]
 
Finger Joint Implant
* Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis [Text] [PDF]
 
Fluoroscopy
* Assessment of the Impact of the Proposed Amendments to the Diagnostic X-ray Equipment Performance Standard addressing Fluoroscopic X-ray Systems (Draft) [Text] [PDF]
* Avoidance of Serious X-Ray-Induced skin Injuries to Patients During Fluroscopically-Guided Procedures   [PDF]
* Concepts for Proposed Amendents to the Performance Standard for Diagnostic X-ray Systems [Text]
* Draft Amendments to the Federal Performance Standard for Diagnostic X-ray Systems and their Major Components   [PDF]
* Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components ; Proposed Rule [Text] [PDF]
* Estimated Benefits of Proposed Amendments to the FDA Radiation-Safety Standard for Diagnostic X-Ray Equipment [Text] [PDF] [PowerPoint PPT]
* Paper on Radiation-induced Skin Injuries from Fluroscopy [Text]
* Proceedings of the ACR/FDA Workshop on Fluoroscopy [Text]
* Public Health Advisory on Avoidance of Seriou sX-Ray-Induced skin Injuries to Patients During Fluroscopically-Guided Procedures [Text]
* Radiation Injuries and Fluoroscopy [Text]
* Recording Information in the Patient's Medical Record that Identifies the Potential for Serious X-Ray Induced Skin Injuries [Text]
 
Foley Catheters
* Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters [Text]
 
Foreign Clinical Studies
* Acceptance of Foreign Clinical Studies; Guidance for Industry [Text] [PDF]
 
Forms
* FDA/CDRH Forms [Text]
* Medical Device Reporting - MDR Forms and Instructions [Text]
 
Fraudulent Devices
* Buying Drugs Online: It's Convenient and Private, but Beware of 'Rogue Sites' [Text]
* FTC and FDA Crackdown on Internet Marketers of Bogus SARS Prevention Products [Text]
* How to Spot Health Fraud [Text]
* Ozone Generators Generate Prison Terms for Couple [Text]
* The Truth About Choosing Medical Treatments [Text]
 
Freedom of Information (FOI) Act
* CDRH Petitions [Text]
* Dockets - Repository for the Administrative Proceedings and Rule-making Documents [Text]
* Freedom of Information (FOI) Reference Sheet [Text]
* How to Get Information From CDRH [Text]
 

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