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Center for Devices and Radiological Health, U.S. Food and Drug Administration

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Index of CDRH Web Documents

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 Or, enter a word or phrase to search for in document titles : (Search Help) Some additional items of interest can be found on the Consumer Information page.

Educational Opportunities
	ODE Site Visit Program
	ODE Vendor Day Program

Electric Heating Pads
	FDA/CPSC Public Health Advisory on Electric Heating Pads

Electrically Powered
	Safety of Electrically Powered Products: Letter To Medical Device and Electronic Product Manufacturers From Lillian Gill & BHB correction memo#

Electro Optical Sensors
	Draft Guidance for Industry: Electro-optical Sensors for the In Vivo Detection of Cervical Cancer and its Precursors: Submission Guidance for an IDE/PMA

Electrocardiographs (ECG)
	Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement); Final
	FDA Clears 3-lead, pocket-sized ECG devices
	Pocket-Sized ECG Machine Cleared By FDA

Electrodes
	Guidance to Sponsors on the Development of a Discretionary Postmarket Surveillance Study for Permanent Implantable Cardiac Pacemaker Electrodes (Leads

Electroencephalograph Devices
	Electroencephalograph Devices Draft Guidance for 510(k) Content

Electromagnetic Interference (EMI)/Electromagnetic Compatibility (EMC)
	Cellular Phone Interference
	Electromagnetic Compatibility
	Electromagnetic Interference (EMI)
	Electromagnetic Interference (EMI) Testing of Medical Devices
	FDA/CDRH Recommendations for EMC/EMI in Healthcare Facilities
	Guidance for Industry: Labeling for Electronic Anti-Theft Systems
	Guidance for Testing MR Interaction with Aneurysm Clips
	Important Information on Anti-Theft and Metal Detector Systems and Pacemakers, ICDs, and Spinal Cord Stimulators
	Keeping Medical Devices Safe from Electromagnetic Interference
	Medical Device Electromagnetic Interference Issues, Problem Reports, Standards, and Recommendations
	Medical Devices and EMI: The FDA Perspective
	Memorandum: Electromagnetic Compatibility for Medical Devices: Issues and Solutions
	MRI (Magnetic Resonance Imaging) Safety
	Risk of Electromagnetic Interference with Medical Telemetry Systems
	Wireless Medical Telemetry - Electromagnetic Interference Concerns and Solutions
	Wireless Medical Telemetry Risks and Recommendations

Electromyography
	Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Electromyograph Needle Electrodes

Electronic Article Surveillance Systems (EAS)
	Electromagnetic Interference (EMI)
	Electromagnetic Interference (EMI) Testing of Medical Devices
	Important Information on Anti-Theft and Metal Detector Systems and Pacemakers, ICDs, and Spinal Cord Stimulators

Electronic Communication
	Desktop Video Conferencing
	Electronic Submissions
	Fax and E-Mail Communication with Industry about Premarket Files Under Review (A02-01)
	Fax On Demand

Electronic Muscle Stimulators
	Consumer Information on Electronic Muscle Stimulators

Electronic Products
	Guidance on Electronic Products which Emit Radiation

Electronic Records and Signatures
	21 CFR Part 11; Electronic Records; Electronic Signatures, Glossary of Terms; Draft Guidance for Industry
	21 CFR Part 11; Electronic Records; Electronic Signatures, Validation; Draft Guidance for Industry
	Draft Guidance for Industry on Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records
	Electronic Records: Documents relating to rule
	Electronic Records;Electronic Signatures
	Part 11, Electronic Records; Electronic Signatures � Scope and Application

Electronic Resonating Components
	Notice about Vacuum Loss in Electronic Resonating Components

Electronic Submissions
	Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--General Considerations
	Electronic Submissions

Electrosurgical Devices
	Draft 510(k) Checklist for Endoscopic Electrosurgical Unit (ESU) and Accessories Used in Gastroenterology and Urology
	Draft 510(k) Guideline for General Surgical Electrosurgical Devices
	Draft Guidance for the Content of Premarket Notifications for Loop and Rollerball Electrodes for GYN Electrosurgical Excisions
	Guidance on Electrosurgical Devices and the Application of the Performance Standard for Electrode Lead Wires and Patient Cables

Embolizing Devices
	Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices - Draft Guidance for Industry and FDA Staff
	Guidance for Neurological Embolization Devices

Emergency Response Plans
	FDA's Office of Crisis Management Emergency Response Plan Summaries

Employee Directory
	Employee Directory

Employment Opportunities
	Employment Opportunities

Endolymphatic Shunt Tube
	Class II Special Controls Guidance Document: Endolymphatic Shunt Tube with Valve; Guidance for Industry and FDA

Endometrial
	Thermal Endometrial Ablation Devices (Submission Guidance for an IDE)

Endoscopy
	Draft 510(k) Checklist for Endoscopic Electrosurgical Unit (ESU) and Accessories Used in Gastroenterology and Urology
	Draft 510(k) Checklist for Endoscopic Light Sources Used in Gastroenterology and Urology
	Draft Guidance for the Content of Premarket Notifications for Endoscopes used in Gastroenterology and Urology
	Draft Version Neuro Endoscope Guidance
	FDA and CDC Public Health Advisory: Infections from Endoscopes Inadequately Reprocessed by an Automated Endoscope Reprocessing System
	Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers; Final
	Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities
	Letter to Medical Device Industry on Endoscopy and Laparoscopy Accessories (Galdi)

Endosseous Implants
	Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of FDA Submissions for Orthopedic and Dental Endosseous Implants

Endotoxins
	Class II Special Controls Guidance Document: Endotoxin Assay
	Guideline on Validation of the Limulus Amebocyte Lysate (LAL) Test as an End-Product Endotoxin Test

Endotracheal
	FDA Public Health Advisory: Occluded Endotracheal Tubes

Endovascular Grafts
	Frequently Asked Questions About Problems With Endovascular Grafts for Treatment of Aortic Abdominal Aneurysms (AAA)
	Proceedings from the Workshop on Preclinical Testing for Endovascular Grafts held July 31 - August 1, 2001

Enforcement
	Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals
	FDA Enforcement Report

Environmental Control
	Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Communications Systems (Powered and Non-Powered) and Powered Environmental Control Systems

Epilepsy
	FDA Approves Medical Device for Epilepsy

Esophageal and Tracheal Prostheses
	Guidance for Content of Premarket Notifications for Esophageal and Tracheal Prostheses; Final

Establishment Registration
	Establishment Registration and Medical Device Listing
	Registration and Listing for Firms
	Search the Establishment Registration Database

Ethylene Oxide
	ANSA/AAMI/ISO 10993-7 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals: Recognized Consensus Standard
	Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene Glycol; Proposed Maximum Residue Limits and Maximum Levels of Exposure

European Community
	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)

Evoked Response Stimulators
	Draft Premarket Notification Review Guidance for Evoked Response Somatosensory Stimulators
	Guidelines for Reviewing Premarket Notifications that Claim Substantial Equivalence to Evoked Response Stimulators

Exemptions, Medical Device
	Class 1 Exemptions - Low Risk Medical Devices
	Medical Device Exemptions: 510(k) and GMP Requirements
	Procedures for Class II Device Exemptions from Premarket Notification Guidance for Industry and CDRH Staff; Final

Exercise Equipment
	Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Exercise Equipment
	Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Submerged (Underwater) Exercise Equipment

Expiration Dating
	Guidance for Conducting Stability Testing To Support An Expiration Date Labeling Claim for Medical Gloves; Draft
	Policy for Expiration Dating (DCRND RB92-G)

Exporting Medical Devices
	FDA Export Reform and Enhancement Act of 1996
	Guidance for Industry: FDA Export Certificates

External Fixation Devices
	Reviewers Guidance Checklist for Orthopedic External Fixation Devices

Extracorporeal
	Draft of Suggested Information for Reporting Extracorporeal Shock Wave Lithotripsy Device Shock Wave Measurements
	Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi

Eye Surgery
	FDA Approves Treatment for Wet Macular Degeneration
	FDA Talk Paper - FDA Approves Eye Implant to Correct Mild Nearsightedness
	LASIK Eye Surgery
	Summary Information for LaserScan LSX Excimer Laser System for Photorefractive Keratectomy for Myopia
	Summary Information on VISX Star S2 and S3 Excimer Laser Systems - P930016/S010
	Vision Correction: Taking a Look at What's New

Eyeglass Devices
	FDA Talk Paper: ColorMax Lenses
	Sunglasses, Spectacle Frames, Spectacle Lens and Magnifying Spectacles
	Vision Correction: Taking a Look at What's New

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Center for Devices and Radiological Health / CDRH