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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.

IDE
	IDE - See Investigational Device Exemptions

Imaging
	Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA
	Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices; Final
	Harmonic Imaging with/without Contrast - Premarket Notification; Final

Immunotoxicity
	Immunotoxicity Testing Guidance

Implantable Cardioverter Defibrillator
	Photon DR Implantable Cardioverter Defibrillator
	Phylax AV Implantable Cardioverter Defibrillator with Program Software

Implants
	510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants
	Final Report: Medical Implant Information, Performance and Policies; Biomaterials and Medical Implant Science (BMIS) Workshop - September 19-20, 2002
	Guidance Document for Testing Biodegradable Polymer Implant Devices
	Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant Components
	Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements
	Refractive Implants: Guidance for Investigational Device Exemptions (IDE) and Premarket Approval (PMA) Applications; Draft

Imports
	Device Advice Overview
	Import Alerts
	Import Detention Reports for OASIS
	Imports Radiation-Producing Electronic Products (FDA 89-8008)
	Letter to All Foreign Manufacturers and Importers of Electronic Products for Which ApplicableDA Performance Standards Exist
	Regulation of Medical Devices: Background Information for International Officials

In Vitro Diagnostics (IVD)
	510(k) Submissions for Coagulation Instruments - Guidance for Industry and FDA Staff
	Assessing the Safety/Effectiveness of Home-use In Vitro Diagnostic Devices (IVDs): Draft Points to Consider Regarding Labeling and Premarket Submissions
	California IVD Firm Signs Consent Decree with FDA: Agrees to Stop Manufacturing; Correct Violations
	Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDa
	Classification Names for Medical Devices and In Vitro Diagnostic Products (FDA Pub No. 95-4246)
	Compliance Policy Guide - Draft Commercialization of In Vitro Diagnostic Devices( IVD's) - Draft Labeled "For Research Use Only" or "For Investigational Use Only
	Draft Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
	Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final
	Guideline for the Manufacture of In Vitro Diagnostic Products
	In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions
	Kit Certification for 510(k)s
	Letter to IVD Manufacturers on Streamlined PMA; Final
	Office of In Vitro Diagnostic Device Evaluation and Safety
	Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Website
	Over The Counter In Vitro Diagnostic Devices
	Points to Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance
	Points to Consider for Review of Calibration and Quality Control Labeling for In Vitro Diagnostic Devices/Cover Letter dated 3/14/1996
	Regulating In Vitro Diagnostic Device (IVD) Studies
	Variance for IVD's - Approval of an Alternative Requirement of the User Labeling Requirements for Devices that Contain Dry Natural Rubber

In Vitro Fertilization
	Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures; Draft
	Letter to: Manufacturers of Medical Devices used for In Vitro Fertilization (IVF) and other Assisted Reproduction Procedures

Incontinence
	Coping with Bladder Problems
	FDA Approves New Incontinence Produc tfor Women
	FDA Clears New Incontinence Product for Women

Incubators
	Neonatal and Neonatal Transport Incubators - Premarket Notifications; Final

Indications for Use
	Indications for Use Statement

Infant Mattresses/Positioners
	Letter: Medical Claims on Labeling and Promotional Materials of Infant Mattresses and Infant Positioners Distributed in the United States

Informed Consent
	Informed Consent

Infusion
	Guidance on 510(k) Submissions for Implanted Infusion Ports
	Guidance on the Content of Premarket Notification [510(k)] Submissions for External Infusion Pumps
	Medtronic IsoMed Constant Flow Infusion System

Infusion Pumps
	Medtronic IsoMed Constant Flow Infusion System

Inhalers
	Metered Dose Inhalers

Injury Prevention
	Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA

Inspections
	Draft Guidance: Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval
	Inspection of Medical Device Manufacturers; Final Guidance for Industry and FDA
	Medical Device Manufacturer's Survey Evaluation of FDA Quality System / Good Manufacturing Practice Inspections
	Requests for Inspection by an Accredited Person Under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002 - Draft Gudiance for Industry, FDA Staff, and FDA-Accredited Third-Pa

Institutional Review Board
	Institutional Review Boards

Insufflators
	Hysteroscopes and Laparoscopic Insufflators: Submission Guidance for a 510(k)

Integrity
	Fax and E-Mail Communication with Industry about Premarket Files Under Review (A02-01)
	FDA Application Integrity Policy Information
	Integrity of Data and Information Submitted to ODE #I91-2 (blue book memo)
	Program Integrity Blue Book Memoranda

Intended Use
	Guidance for Industry; General/Specific Intended Use; Final

Interagency Agreements
	Interagency Agreement Between FDA and HCFA;Categorizationof Investigational Devices for Coverage under Medicare

Intercenter Agreements
	Intercenter Agreement Between the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health - Biologics and Devices
	Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health. Drugs and Devices
	Intercenter Consultative/Collaborative Review Process (#G02-1)

International
	CDRH International Program
	Global Harmonization Task Force Website
	Regulation of Medical Devices: Background Information for International Officials

Internet
	Agencies Team Up In War Against Internet Health Fraud
	Buying Contact Lenses on the Internet, by Phone or by Mail: Questions and Answers
	Buying Drugs Online: It's Convenient and Private, but Beware of 'Rogue Sites'
	Buying Medical Devices Online
	Consumer Information About Buying Prescription Drugs and Medical Products Online
	FDA And The Internet: Advertising and Promotion of Medical Products, October 16-17,1996 (Meeting Transcripts)
	FDA Joins with FTC & Others Against Internet Health Fraud
	Medwatch Reporting Via Internet
	Reporting Unlawful Sales of Medical Products on the Internet

Internet Sales
	Agencies Team Up In War Against Internet Health Fraud
	Buying Contact Lenses on the Internet, by Phone or by Mail: Questions and Answers
	Buying Drugs Online: It's Convenient and Private, but Beware of 'Rogue Sites'
	Buying Medical Devices Online
	Consumer Information About Buying Prescription Drugs and Medical Products Online
	FDA And The Internet: Advertising and Promotion of Medical Products, October 16-17,1996 (Meeting Transcripts)
	FDA Joins with FTC & Others Against Internet Health Fraud
	FTC and FDA Crackdown on Internet Marketers of Bogus SARS Prevention Products
	Reporting Unlawful Sales of Medical Products on the Internet

Intramedullary Rods
	Reviewers Guidance Checklist for Intramedullary Rods

Intraocular Lens (IOL)
	Approval of CeeOn UV Absorbing Posterior Chamber IOL
	FDA Approves Implanted Lens to Correct Nearsightedness

Investigational Device Exemptions (IDEs)
	BLUE BOOK MEMORANDA - IDE
	Center for Devices and Radiological Health's Investigational Device Exemption (IDE) Refuse to Accept Policy
	Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff
	Device Advice: Clinical Trials and Investigational Device Exemptions
	Financial Interest Form: Certification: Financial Interests and Arrangements of Clinical Investigations FDA Form 3454
	Financial Interest Forms: Disclosure: Financial Interests and Arrangements of Clinical Investigators FDA Form 3455
	Format for IDE Progress Reports
	Goals and Initiatives for the IDE Program #D95-1 (blue book memo)
	Guidance Document for the Preparation of IDEs for Spinal Systems
	Guidance for Industry: Financial Disclosure by Clinical Investigators
	Guidance for Industry; Collection of Race and Ethnicity Data in Clinical Trials (Draft Guidance)
	Guidance for Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport, and Storage of Organs for Transplantation; Final Guidance for Industry and FDA Reviewers
	Guidance on IDE Policies and Procedures; Final
	HCFA Reimbursement Categorization Determinations for FDA-approved IDEs
	Human Factors Points to Consider for IDE Devices
	IDE - See Investigational Device Exemptions
	IDE Refuse to Accept Procedures #D94-1 (blue book memo)
	Investigational Device Exemptions [IDE] Manual (FDA 96-4159)\DSMICA
	New IDE / PMA Development and Review Model and Pilots
	Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects
	Procedures for Handling Inquiries Regarding the Need for an Investigational Device Exemptions Application for Research Involving Medical Devices (Blue Book Memorandum D01-1)
	Review of IDEs for Feasibility Studies #D89-1 (blue book memo)
	Suggested Content for Original IDE Application Cover Letter

Irrigation
	Draft 510(k) Checklist for Urological Irrigation System and Tubing Set

IUDs
	Guidelines for Evaluation of Non-Drug IUDs

IV Pumps
	Avoiding Injuries From Rapid Drug or I.V. Fluid Administration Associated WithI.V. Pumps And Rate-Controller Devices

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Center for Devices and Radiological Health / CDRH