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Macular Degeneration |
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FDA Approves Treatment for Wet Macular Degeneration |
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Magnetic Resonance Imaging (MRI) |
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Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and FDA Staff |
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Draft Document - A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems |
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Guidance for Testing MR Interaction with Aneurysm Clips |
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Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Final |
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MRI (Magnetic Resonance Imaging) Safety |
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Study of Rupture of Silicone Gel-filled Breast Implants (MRI Component) |
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Magnets |
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Consumer Information on Magnets |
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Magnifying Spectacles |
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Sunglasses, Spectacle Frames, Spectacle Lens and Magnifying Spectacles |
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Mammography |
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Brochure: Mammography Today: Questions and Answers for Patients on Being Informed Consumers |
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Closed Facilities: Strategies for Ensuring Patients' Access to Medical Records |
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Digital Mammography |
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FDA Approves First Digital Mammography System |
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FDA's Mammography Program |
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Guidance for Industry and FDA Staff on the Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System 6 |
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Information for Consumers on Digital Mammography in Q & A Format |
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Mammogram Law Takes Effect April 28, 1999 |
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Mammograms and Breast Cancer Brochure |
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Mammograms and Breast Cancer Brochure - Easy To Read Publication |
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Mammography Facility Adverse Event and Action Report 2002 |
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Mammography Facility Adverse Event Report - 2000 |
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Mammography Facility Satisfaction Survey Highlights |
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MQSA Program Accomplishments June 1993 through June 2001 |
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MQSA Warning Letters: Road to Corrective Action |
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Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDA |
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The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #7; Guidance for Industry and FDA |
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Mammography Quality and Radiation Programs |
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About Mammography (MQSA) |
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Breast Implant Adverse Events During Mammography |
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FDA's Mammography Program |
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Mammography (MQSA) Consumer Issues |
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Mammography (MQSA) Facilities |
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Mammography (MQSA) Guidance |
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Mammography (MQSA) Publications |
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MQSA Program Accomplishments June 1993 through June 2001 |
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Manufacturer and User Facility Device Experience (MAUDE) Database |
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Manufacturer and User Facility Device Experience (MAUDE) Database Files |
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Manufacturing Practice |
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Good Clinical Practice in FDA-Regulated Clinical Trials |
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Maps |
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Map of CDRH and Other FDA Facility Locations |
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Massagers |
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Guidance Document for the Preparation of Notification (510(k)) Applications for Therapeutic Massagers and Vibrators |
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Master Files |
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Master Files Part III; Guidance on Scientific and Technical Information |
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MAUDE |
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Manufacturer and User Facility Device Experience (MAUDE) Database Files |
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See also : Medical Device Reporting (MDR) |
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MDR |
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See also : Medical Device Reporting (MDR) |
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Mechnically Locked |
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Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant Components |
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Medical Device Reporting (MDR) |
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Alternative Summary Reporting |
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Guidance for Industry: Medical Device Reporting - Alternative Summary Reporting (ASR) Program |
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Guidance on Adverse Event Reporting for Hospitals that Reprocess Devices Intended by the Original Equipment Manufacturer for Single Use |
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Instructions for Completing Form 3417: Medical Device Reporting Baseline Report [MDR] |
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Instructions for completing Semi-Annual Report, Form 3419 (MDR) |
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Mandatory MedWatch Reporting Form 3500A - Codes Manual |
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Manufacturer and User Facility Device Experience (MAUDE) Database Files |
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MDR Data |
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MDR General Information |
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MDR Guidance Document No. 1 - IOL - E1996004 |
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Medical Device Reporting - MDR Forms and Instructions |
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Medical Device Reporting - Remedial Action Exemption; Guidance for Industry and FDA |
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Medical Device Reporting for Manufacturers |
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Medical Device Reporting for User Facilities |
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Medical Device Reporting: An Overview |
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Needlesticks - Medical Device Reporting Guidance for User Facilities, Manufacturers, and Importers |
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Variance from Manufacturer Report Number Format |
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Variance from Manufacturer Report Number Format [MDR letter] |
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Medical Device User Fee and Modernizaton Act of 2002 (MDUFMA) |
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Bundling Multiple Devices or Multiple Indications in a Single Submission - Guidance for Industry and FDA Staff |
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Expedited Review of Premarket Submissions for Devices - Guidance for Industry and FDA Staff |
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FDA 3602 - FY2004 MDUFMA Small Business Qualification Certification |
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FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Performance Assessment - Guidance for Industry and FDA Staff |
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FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment - Guidance for Industry and FDA Staff |
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FY 2005 MDUFMA Small Business Qualification Worksheet and Certification - Guidance for Industry and FDA |
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Information on the Medical Device User Fee and Modernization Act (MDUFMA) of 2002 |
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Premarket Approval Application Modular Review - Guidance for Industry and FDA Staff |
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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 |
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Strategic Plan - Reducing Device Approval Times |
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User Fees and Refunds for Premarket Approval Applications - Guidance for Industry and FDA Staff |
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User Fees and Refunds for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff |
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Medical Devices |
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Activities of FDA's Medical Product Centers in 2001 |
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Brochure: Better Health Care with Quality Medical Devices |
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Brochure: Home Healthcare Medical Devices: A Checklist |
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Buying Medical Devices Online |
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FDA Performance Plan FY2002 - Medical Devices and Radiological Health |
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FDA's Report on New Health Care Products Approved in 2000 |
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Future Trends in Medical Device Technology: Results of an Expert Survey |
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New Model Medical Device Development Process; Final |
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Regulation of Medical Devices: Background Information for International Officials |
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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 |
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Medical Gas |
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FDA Public Health Advisory - Potential for Injury from Medical Gas Misconnections of Cryogenic Vessels |
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Medical Imaging |
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Medical Imaging - see Diagnostic Imaging |
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Medwatch Reporting |
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Common Problems: Baseline Reports and MedWatch Form 3500A (letter to manufacturers updated) |
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Instructions for Completing FDA Form 3500A with Coding Manual for Form 3500A (MEDWATCH) |
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MEDWATCH FDA Form 3500A For Use By User Facilities, Distributors and Manufacturers for Mandatory Reporting |
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Medwatch Reporting Via Internet |
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User Facility Reporting Bulletins |
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Meetings |
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Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff |
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Meetings with the Regulated Industry #I89-3 (blue book Memo) |
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Menopause |
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Menopause Home Use Test |
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Mercury Amalgams |
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Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling; Draft Guidance for Industry and FDA |
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Mercury Vapor Lamps |
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Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps |
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Quality Control Practices for Compliance with the Federal Mercury Vapor Lamp Performance Standard |
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Reporting Guide for Product Reports on High Intensity Mercury Vapor Discharge Lamps (21 CFR 1002) |
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Metallic Plasma Sprayed |
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Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements |
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Microwaves |
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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 |
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Consumer Information: Microwave Oven Radiation |
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Guidance on Electronic Products which Emit Radiation |
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Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264)] |
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Guide for Preparing Abbreviated Reports of Microwave and RF Emitting Electronic Products Intended for Medical Use |
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Guide for Preparing Reports on Radiation Safety of Microwave Ovens |
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Information Requirements for Cookbooks and User and Service Manuals |
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Keeping Up With the Microwave Revolution (FDA Pub No. 91-4160) |
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Letter to All Manufacturers and Importers of Microwave Ovens: Retention of Records Required by 21 CFR 1002 |
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Open Door Operation of Microwave Ovens as a Result of Oven Miswiring |
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Risk of Burns from Eruptions of Hot Water Overheated in Microwave Ovens |
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Mission |
|
Center for Devices and Radiological Health - Overview |
|
|
Mobile Phones |
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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 |
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|
Model Numbers |
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Reporting of New Model Numbers to Existing Model Families |
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|
|
Modernization Act of 1997 |
|
FDA Modernization Act of 1997 |
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|
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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 |
|
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|
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 |
|
|