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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.

Safe Medical Devices Act (SMDA)
	515(i) Reclassification Letter to Manufacturers
	SMDA Changes - PMA Manual Insert
	SMDA Changes - Premarket Notification; Regulatory Requirements for Medical Devices (510k) Manual Insert

Safety Alerts, Public Health Advisories and Notices
	FDA Warning Letters Database
	Health Advisories and Safety Alerts
	Product Recalls, Alerts, and Warnings

SARS
	FTC and FDA Crackdown on Internet Marketers of Bogus SARS Prevention Products
	SARS Diagnostics: Scientific and Regulatory Challenges Workshop - July 14, 2003 - Presentations and Transcript
	Severe Acute Respiratory Syndrome (SARS)

Satellite Videoconferencing
	Division of Communication Media

Scanning
	Whole Body Scanning Using Computed Tomography (CT)

Scarring
	CosmoDerm™ 1 Human-Based Collagen, CosmoDerm™ 2 Human-Based Collagen and CosmoPlast™ Human-Based Collagen

Science Review
	Science at Work in CDRH: A Report on the Role of Science in the Regulatory Process; Final Report

Scoliosis
	Reducing Patient Exposure During Scoliosis Radiography

Scorecards
	Scorecard Reports

Sealer
	Guide for Submission of Information on Industrial Radiofrequency Dielectric Heater and Sealer Equipment Pursuant to 21 CFR 1002.10 and 1002.12 (FDA 81-8137)

Sexual Therapy Devices
	FDA Clears New Female Sexual Therapy Device

Sexually Transmitted Disease (STD) Protection
	Letter - Manufacturers, Importers, and Repackagers of Condoms for Contraception or Sexually-Transmitted Disease Prevention (Holt)
	Prospective Manufacturers of Barrier Devices used during Oral Sex for STD Protection

Sexually Transmitted Diseases (STDs)
	FDA Approves Expanded Use of HPV Test
	On the Teen Scene: Preventing STDs

Sharps
	Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers
	Manufacturers and Initial Distributors of Sharps Containers and Destroyers Used by Health Care Professionals
	NeedleZap
	Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry and FDA
	Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA

Sheaths
	Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers; Final

Shelf Life
	Shelf Life of Medical Devices

Shunts
	Shunt Technology: Challenges and Emerging Directions

SIDS (Sudden Infant Death Syndrome)
	Letter: Medical Claims on Labeling and Promotional Materials of Infant Mattresses and Infant Positioners Distributed in the United States

Silicone
	Breast Implants Information
	Guidance for Saline, Silicone Gel, and Alternative Breast Implants; Guidance for Industry and FDA
	Study of Silicone Gel Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women

Single Use Devices
	FDA Talk Paper: FDA Revises Guidance on Reprocessing of Single-Use Devices
	Single Use Devices - See Reuse

Sirolimus
	Guidance for Industry and FDA Staff; Class II Special Controls Guuidance Document: Sirolimus Test Systems

Site Visits
	ODE Site Visit Program

Six Year Rule
	Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997

Skin
	Cyanoacrylate Tissue Adhesive for the Topical Approximation of Skin - Premarket Approval Applications (PMAs) - Guidance for Industry and FDA Staff
	FDA Approves Adhesive for Skin Wound Closure
	Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products; Final

Skin Fillers
	FDA Approves Sculptra for HIV Patients

Sleep Apnea
	Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA

Small Business
	FDA 3602 - FY2004 MDUFMA Small Business Qualification Certification
	FY 2005 MDUFMA Small Business Qualification Worksheet and Certification - Guidance for Industry and FDA
	Reduction of Civil Money Penalties for Small Entities; Guidance for Industry and FDA Staff
	Small Business Guide to FDA (FDA 96-1092)

Snoring
	Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA

Software
	Computer Aided Diagnosis - Open Public Workshop Meeting Summary
	Computer-Controlled Potentially High-Risk Medical Devices - List of Device Types
	Computerized Systems Used in Clinical Trials
	FDA Policy For The Regulation Of Computer Products (DRAFT)
	General Principles of Software Validation; Final Guidance for Industry and FDA Staff
	Glossary of Computerized System and Software Development Terminology, August 1995
	Guidance for Off-the-Shelf Software Use in Medical Devices; Final
	Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Final
	Review of 510(k)s for Computer Controlled Medical Devices #K91-1 (blue book memo)
	Y2K Issue for Production Processes and Quality System Software

Solid
	Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices; Final

Spanish Language Publications
	Mejor Cuidado de la Salud Con Dispositivos Médicos de Calidad: FDA a la Cabeza en Tecnología de Dispositivos Médicos
	Spanish Language Brochures

Spectacle Frames
	Sunglasses, Spectacle Frames, Spectacle Lens and Magnifying Spectacles

Spectacle Lens
	Sunglasses, Spectacle Frames, Spectacle Lens and Magnifying Spectacles

Spinal
	Complications Related to the Use of Bone Cement in Treating Compression Fractures of the Spine - FDA Public Health Web Notification
	FDA Approves New Spinal Fusion Device
	Guidance Document for the Preparation of IDEs for Spinal Systems
	Spinal System 510(k)s - Guidance for Industry and FDA Staff

Staff
	Center for Devices and Radiological Health - Organizational Structure
	Center for Devices and Radiological Health - Referral List

Stakeholder Information
	CDRH Stakeholder Information

STAMP
	Shunt Technology: Challenges and Emerging Directions

Standards Program
	CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standards for Recognition; Final Guidance for Industry
	CDRH Standards Program
	Frequently Asked Questions on the Recognition of Consensus Standards; Guidance for Industry and for FDA Staff
	Guidance on the Use of Standards in Substantial Equivalence Determinations; Final
	Opportunity to Recommend Standards for CDRH Recognition
	Recognition and Use of Consensus Standards; Final Guidance for Industry and FDA
	Required Elements for a Declaration of Conformity to a Recognized Standard - (Screening Checklist for All Premarket Notification [510(k)] Submissions)
	Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (Replaces #G87-1 #8294) (blue book memo)

Statistics
	Perspectives on Clinical Studies for Medical Device Submissions (Statistical)
	PMA Review Statistical Checklist
	Statistical Aspects of Submissions to FDA: A Medical Device Perspective (also includes as Appendix the article Observed Uses and Abuses of Statistical Procedures in Medical Device Submissions
	Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests; Draft Guidance for Industry and FDA Reviewers

Stents
	Dear Colleague Letter: NIR ON Ranger w/SOX Premounted Stent System
	Draft Guidance for the Clinical Investigation of Urethral Stents
	Drug-Eluting Cardiovascular Stents - Request for Designation
	FDA Advises Physicians of Adverse Events Associated with Cordis Cypher Coronary Stents (FDA Talk Paper)
	FDA Approves Drug-Eluting Stent for Clogged Heart Arteries
	FDA Approves Stent for Urinary Obstruction in Men
	FDA Approves Two New Devices to Help Reduce the Risk of Repeat Coronary Stent Re-Narrowing (In-Stent Restenosis)
	FDA Public Health Notification: Updated Data on Mortality Associated with Medtronic AVE AneuRx® Stent Graft System
	FDA Public Health Web Notification: Information for Physicians on Sub-acute Thromboses (SAT) and Hypersensitivity Reactions with Use of the Cordis CYPHER™ Coronary Stent
	Frequently Asked Questions About Problems With Endovascular Grafts for Treatment of Aortic Abdominal Aneurysms (AAA)
	Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents; Final
	Guidance for the Content of Premarket Notifications for Ureteral Stents
	Summary of October 2002 Advisory Meeting to Discuss Approval of Drug Coated Stent

Sterilants/High Level Disinfectants
	Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene Glycol; Proposed Maximum Residue Limits and Maximum Levels of Exposure
	Sterilants and High Level Disinfectants Cleared by FDA in a 510(k) with General Claims for Processing Reusable Medical and Dental Devices

Sterility
	Application of the Device Good Manufacturing Practice (GMP) Regulation to the Manufacture of Sterile Devices
	Dental Handpiece Sterilization (Dear Doctor Letter)
	Guidance ('Guidelines') for Evaluation of Hysteroscopic Sterilization Devices
	Guideline on Sterile Drug Products Produced by Aseptic Processing
	ORDB 510(k) Sterility Review Guidance
	Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA
	Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA

Sterilization Devices
	FDA Approves New Female Sterilization Device

Sterilizers
	Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities
	Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene Glycol; Proposed Maximum Residue Limits and Maximum Levels of Exposure
	Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities
	New Policy Concerning PMA Postmarket Inspections of Contract Sterilizers
	Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA
	Premarket Notifications [510(k)] for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA Reviewers

Stimulator
	Consumer Alert on the Stimulator
	Consumer Information on Electronic Muscle Stimulators
	Draft 510(k) Checklist for Non-Implanted Electrical Stimulators Used for the Treatment of Urinary Incontinence
	Draft Premarket Notification Review Guidance for Evoked Response Somatosensory Stimulators
	Draft Version Guidance for Clinical Data to be Submitted for Premarket Approval Application for Cranial Electrotherapy Stimulators
	FDA Approves Expanded Use of Brain Implant for Parkinson's Disease
	FDA Approves Implanted Brain Stimulator to Control Tremors
	FDA Public Health Notification: Diathermy Interactions with Implanted Leads and Implanted Systems with Leads
	FDA Talk Paper: Scheme to Sell Gas Grill Igniters for Pain Relief Backfires; Court Orders Refund to Purchasers
	Guidance Document for Industry and CDRH staff for the Preparation of Investigational Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices; Draft
	Guidance Document for Powered Muscle Stimulator 510(k)s; Final
	Guidelines for Reviewing Premarket Notifications that Claim Substantial Equivalence to Evoked Response Stimulators
	Important Information on Anti-Theft and Metal Detector Systems and Pacemakers, ICDs, and Spinal Cord Stimulators
	Neurological Devices Panel, March 31, 2000 - Bilateral Deep Brain Stimulator

Stomach Band
	FDA Approves Implanted Stomach Band to Treat Severe Obesity

Strategic Plan
	CDRH Strategic Plan
	FDA Launches Initiative to Improve the Development and Availability of Innovative Medical Products
	Improving Innovation in Medical Technology: Beyond 2002
	Improving Innovation in Medical Technology: Beyond 2002 - Executive Summary
	Strategic Plan - Reducing Device Approval Times
	Strategic Planning: Taking Us Into the Future - September 2001

Studios
	Division of Communication Media

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

Substantial Equivalence
	Substantial Equivalence (SE) Decision Making Documentation ATTACHED: 'SE' Decision Making Process (Detailed) i.e. the decision making tree

Sunglasses
	Sunglasses, Spectacle Frames, Spectacle Lens and Magnifying Spectacles

Sunlamps
	Compliance Program Guidance Manual: Field Implementation of the Sunlamp and Sunlamp Product Performance Standard, as amended; Final Guidance for Industry and FDA
	Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers
	Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products
	Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (21-CFR 1002)
	Policy on Lamp Compatibility (sunlamps)
	Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products
	Policy on Warning Label Required on Sunlamp Products
	Quality Control Guide for Sunlamp Products (FDA 88-8234)

Surgeon's Gloves
	Draft Medical Glove Guidance Manual
	Premarket Approval Applications (PMA) for Absorbable Powder for Lubricating a Surgeon’s Glove - Guidance for Industry and FDA Staff
	Statement by Elizabeth D. Jacobson Acting Director CDRH, FDA, DHS, Before the Subcommittee on Oversight And Investigations Re: regulations of natural rubber latex gloves
	Surgeon's and Patient Examination Gloves; Reclassification and Medical Glove Guidance Manual Availability; Proposed Rule and Notice

Surgical Drapes
	Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes

Surgical Gowns
	Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes

Surgical Lamps
	Guidance Document for Surgical Lamp 510(k)s; Final

Surgical Masks
	Surgical Masks - Premarket Notification [510(k)] Submissions; Guidance for Industry and FDA

Surgical Mesh
	FDA Public Health Web Notification: Counterfeit Polypropylene Mesh
	Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; Final

Surgical Staplers
	Surgical Stapler Information

Synvisc/Hyalgan Knee Injection For Osteoarthritis
	Hyalgan
	Synvisc

Syringes
	Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes
	Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA

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Center for Devices and Radiological Health / CDRH