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February 23, 2000 - Y2K Device Status Update
Update Regarding the 2000 Leap Year Transition		HTML

January 3, 2000 - Y2K Device Status Update
Update Regarding the Year 2000 Transition		HTML

January 1, 2000 - Y2K Device Status Update
Update Regarding the Year 2000 Transition		HTML

December 30, 1999 - FDA Important Notice
Important Information Regarding the Year 2000 Transition		HTML

December 13, 1999 - FDA Public Health Notification
Important Information About Y2K and Medical Devices		HTML

December 10, 1999 - Letter to Industry
Update on Y2K Activities Regarding Biomedical Equipment Distribution of Medical Devices After January 1, 2000 Reporting Y2K Problems to FDA	PDF	HTML	DOC

November 17, 1999 - Information for Industry, Healthcare Facilities, and Consumers
Report on the Evaluation of Manufacturers' Activities to Assess the Year 2000 Compliance Status of Their Medical Devices (Computer-Controlled Potentially High-Risk Medical Devices (PHRD) Study Final Report)	PDF	HTML	DOC

November 17, 1999 - Information for Industry, Healthcare Facilities, and Consumers
Report on the Y2K Readiness Survey of Manufacturers of Essential Medical Supplies	PDF	HTML	DOC

October 28, 1999 - Information for Industry, Healthcare Facilities, and Consumers
Y2K and FDA - Preparing for the New Millennium "FDA Consumer Magazine", November-December 1999		HTML

October 21, 1999 - Congressional Testimony
House Committee on Commerce Subcommittee on Health and Environment and Subcommittee on Oversight and Investigations		HTML

September 22, 1999 - Y2K Meeting the Challenge
Year 2000 and Medical Devices		HTML

September 17, 1999 - Information for Healthcare Facilities
User Facility Reporting Bulletin - Summer 1999	PDF

August 24, 1999 - FDA Talk Paper
The Year 2000 Date Problem and Medical Devices		HTML

August 24, 1999 - Information for Industry and Healthcare Facilities
Computer-Controlled Potentially High-Risk Medical Devices - List of Device Types	PDF	HTML	DOC

August 16, 1999 - Federal Register Notice
Agency Emergency Processing Under OMB Review; Survey of Biomedical Equipment Manufacturers	PDF	HTML

August 13, 1999 - Information for Healthcare Facilities and Consumers
Press Release from the President's Council on Year 2000 Conversion	An Open Letter

August 10, 1999 - Information for Industry, Healthcare Facilities, and Consumers
List of Frequently Asked Questions & Answers	Frequently Asked Questions

August 5, 1999 - Links to Y2K Related Sites
Global Harmonization Task Force (GHTF) Y2K Presentations	List of Y2K Presentations

July 30, 1999 - Federal Register Notice
Computer-Controlled Potentially High Risk Medical Devices-List of Device Types	PDF	HTML

July 16, 1999 - Guidance for Industry and Healthcare Facilities
MDR Exemption for Y2K Problems	PDF	HTML

July 16, 1999 - Information for Healthcare Facilities
FDA Public Health Notification - Y2K Planning Information	PDF	HTML	DOC

June 18, 1999 - Letter to Industry
Y2K Readiness Survey of Manufacturers of Essential Medical Supplies	Letter and Attachments

May 10, 1999 - Federal Register Notice
Survey of Medical Device Manufacturers for Year 2000 Compliance of Manufacturing Systems	PDF	HTML

April 26, 1999 - Guidance for Industry
Year 2000 (Y2K) Computer Compliance		HTML

April 20, 1999 - Congressional Testimony
U.S. Senate - Committee on Veterans' Affairs		HTML

April 16, 1999 - Guidance for Industry
MDR Reporting Guidance for Date-Related Problems Including Y2K	PDF	HTML

March 29, 1999 - Letter to Industry
Request for Information on Y2K Compliant Products	Letter and Attachments

March 3, 1999 - Letter to Industry
Request for Additional Information on Non-Compliant Products	Letter and Attachments