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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.

Macular Degeneration
	FDA Approves Treatment for Wet Macular Degeneration

Magnetic Resonance Imaging (MRI)
	Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and FDA Staff
	Draft Document - A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems
	Guidance for Testing MR Interaction with Aneurysm Clips
	Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Final
	MRI (Magnetic Resonance Imaging) Safety
	Study of Rupture of Silicone Gel-filled Breast Implants (MRI Component)

Magnets
	Consumer Information on Magnets

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

Mammography
	Brochure: Mammography Today: Questions and Answers for Patients on Being Informed Consumers
	Closed Facilities: Strategies for Ensuring Patients' Access to Medical Records
	Digital Mammography
	FDA Approves First Digital Mammography System
	FDA's Mammography Program
	Guidance for Industry and FDA Staff on the Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System 6
	Information for Consumers on Digital Mammography in Q & A Format
	Mammogram Law Takes Effect April 28, 1999
	Mammograms and Breast Cancer Brochure
	Mammograms and Breast Cancer Brochure - Easy To Read Publication
	Mammography Facility Adverse Event and Action Report 2002
	Mammography Facility Adverse Event Report - 2000
	Mammography Facility Satisfaction Survey Highlights
	MQSA Program Accomplishments June 1993 through June 2001
	MQSA Warning Letters: Road to Corrective Action
	Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDA
	The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #7; Guidance for Industry and FDA

Mammography Quality and Radiation Programs
	About Mammography (MQSA)
	Breast Implant Adverse Events During Mammography
	FDA's Mammography Program
	Mammography (MQSA) Consumer Issues
	Mammography (MQSA) Facilities
	Mammography (MQSA) Guidance
	Mammography (MQSA) Publications
	MQSA Program Accomplishments June 1993 through June 2001

Manufacturer and User Facility Device Experience (MAUDE) Database
	Manufacturer and User Facility Device Experience (MAUDE) Database Files

Manufacturing Practice
	Good Clinical Practice in FDA-Regulated Clinical Trials

Maps
	Map of CDRH and Other FDA Facility Locations

Massagers
	Guidance Document for the Preparation of Notification (510(k)) Applications for Therapeutic Massagers and Vibrators

Master Files
	Master Files Part III; Guidance on Scientific and Technical Information

MAUDE
	Manufacturer and User Facility Device Experience (MAUDE) Database Files
	See also : Medical Device Reporting (MDR)

MDR
	See also : Medical Device Reporting (MDR)

Mechnically Locked
	Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant Components

Medical Device Reporting (MDR)
	Alternative Summary Reporting
	Guidance for Industry: Medical Device Reporting - Alternative Summary Reporting (ASR) Program
	Guidance on Adverse Event Reporting for Hospitals that Reprocess Devices Intended by the Original Equipment Manufacturer for Single Use
	Instructions for Completing Form 3417: Medical Device Reporting Baseline Report [MDR]
	Instructions for completing Semi-Annual Report, Form 3419 (MDR)
	Mandatory MedWatch Reporting Form 3500A - Codes Manual
	Manufacturer and User Facility Device Experience (MAUDE) Database Files
	MDR Data
	MDR General Information
	MDR Guidance Document No. 1 - IOL - E1996004
	Medical Device Reporting - MDR Forms and Instructions
	Medical Device Reporting - Remedial Action Exemption; Guidance for Industry and FDA
	Medical Device Reporting for Manufacturers
	Medical Device Reporting for User Facilities
	Medical Device Reporting: An Overview
	Needlesticks - Medical Device Reporting Guidance for User Facilities, Manufacturers, and Importers
	Variance from Manufacturer Report Number Format
	Variance from Manufacturer Report Number Format [MDR letter]

Medical Device User Fee and Modernizaton Act of 2002 (MDUFMA)
	Bundling Multiple Devices or Multiple Indications in a Single Submission - Guidance for Industry and FDA Staff
	Expedited Review of Premarket Submissions for Devices - Guidance for Industry and FDA Staff
	FDA 3602 - FY2004 MDUFMA Small Business Qualification Certification
	FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Performance Assessment - Guidance for Industry and FDA Staff
	FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment - Guidance for Industry and FDA Staff
	FY 2005 MDUFMA Small Business Qualification Worksheet and Certification - Guidance for Industry and FDA
	Information on the Medical Device User Fee and Modernization Act (MDUFMA) of 2002
	Premarket Approval Application Modular Review - Guidance for Industry and FDA Staff
	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
	Strategic Plan - Reducing Device Approval Times
	User Fees and Refunds for Premarket Approval Applications - Guidance for Industry and FDA Staff
	User Fees and Refunds for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff

Medical Devices
	Activities of FDA's Medical Product Centers in 2001
	Brochure: Better Health Care with Quality Medical Devices
	Brochure: Home Healthcare Medical Devices: A Checklist
	Buying Medical Devices Online
	FDA Performance Plan FY2002 - Medical Devices and Radiological Health
	FDA's Report on New Health Care Products Approved in 2000
	Future Trends in Medical Device Technology: Results of an Expert Survey
	New Model Medical Device Development Process; Final
	Regulation of Medical Devices: Background Information for International Officials
	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

Medical Gas
	FDA Public Health Advisory - Potential for Injury from Medical Gas Misconnections of Cryogenic Vessels

Medical Imaging
	Medical Imaging - see Diagnostic Imaging

Medwatch Reporting
	Common Problems: Baseline Reports and MedWatch Form 3500A (letter to manufacturers updated)
	Instructions for Completing FDA Form 3500A with Coding Manual for Form 3500A (MEDWATCH)
	MEDWATCH FDA Form 3500A For Use By User Facilities, Distributors and Manufacturers for Mandatory Reporting
	Medwatch Reporting Via Internet
	User Facility Reporting Bulletins

Meetings
	Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff
	Meetings with the Regulated Industry #I89-3 (blue book Memo)

Menopause
	Menopause Home Use Test

Mercury Amalgams
	Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling; Draft Guidance for Industry and FDA

Mercury Vapor Lamps
	Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps
	Quality Control Practices for Compliance with the Federal Mercury Vapor Lamp Performance Standard
	Reporting Guide for Product Reports on High Intensity Mercury Vapor Discharge Lamps (21 CFR 1002)

Metallic Plasma Sprayed
	Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements

Microwaves
	Abbreviated Reports on Radiation Safety for Microwave Products (Other Than Microwave Ovens)- E.G. Microwave Heating, Microwave Diathermy, RF Sealers, Induction, Dielectric Heaters, Security Systems
	Consumer Information: Microwave Oven Radiation
	Guidance on Electronic Products which Emit Radiation
	Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264)]
	Guide for Preparing Abbreviated Reports of Microwave and RF Emitting Electronic Products Intended for Medical Use
	Guide for Preparing Reports on Radiation Safety of Microwave Ovens
	Information Requirements for Cookbooks and User and Service Manuals
	Keeping Up With the Microwave Revolution (FDA Pub No. 91-4160)
	Letter to All Manufacturers and Importers of Microwave Ovens: Retention of Records Required by 21 CFR 1002
	Open Door Operation of Microwave Ovens as a Result of Oven Miswiring
	Risk of Burns from Eruptions of Hot Water Overheated in Microwave Ovens

Mission
	Center for Devices and Radiological Health - Overview

Mobile Phones
	Cooperative Research and Development Agreement (CRADA) - Health Effects of RF Emissions from Wireless Phones (Mobile Units for Commercial Mobile Radio Services)
	FDA and CTIA To Collaborate On Cell Phone Research

Model Numbers
	Reporting of New Model Numbers to Existing Model Families

Modernization Act of 1997
	FDA Modernization Act of 1997
	FDA Modernization Act of 1997: Guidance for the Device Industry on Implementation of Highest Priority Provisions; Availability
	Federal Register Notices Pertaining to the FDA Modernization Act of 1997
	Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997
	Guidance Pertaining to the FDA Modernization Act
	List of Accredited Persons for 510(k) Review under the FDA Modernization Act of 1997
	Overview of FDA Modernization Act of 1997, Medical Device Provisions

Monitors
	FDA Approves New Fetal Oxygen Saturation Monitor
	Intrapartum Continuous Monitors for Fetal Oxygen Saturation and Fetal pH; Submission Guidance for a PMA; Draft Document

Movement Disorders
	FDA Grants Expanded Use of Brain Implant for Movement Disorder

MQSA
	MQSA - See Mammography Quality Radiation Programs

Mutual Recognition Agreement (MRA)
	DRAFT Guidance for Staff, Industry and U.S./EU CABs; Implementation Plan for the MRA between the EU and the USA: Confidence Building Program: Overview, Medical Device Annex, Version 7 June 29, 2000
	DRAFT Guidance for Staff, Industry and U.S./EU CABs; Implementation Plan for the MRA between the EU and the USA: Confidence Building Program: Procedures, Medical Device Annex, Version 7 June 29, 2000
	Fourth Annual Report of the Medical Devices Annex to the U.S. / EC Mutual Recognition Agreement (MRA)
	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)
	US/EU Mutual Recognition Agreement

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Center for Devices and Radiological Health / CDRH