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These documents are available in one or more of the following file formats: Adobe Acrobat (PDF), Microsoft Word 97 (DOC), and/or HTML-text. By following these simple instructions you will be on your way: | |||
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February 23, 2000 - Y2K Device Status Update | |||
Update Regarding the 2000 Leap Year Transition | HTML | ||
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January 3, 2000 - Y2K Device Status Update | |||
Update Regarding the Year 2000 Transition | HTML | ||
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January 1, 2000 - Y2K Device
Status Update | |||
Update Regarding the Year 2000 Transition | HTML | ||
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December 30, 1999 - FDA Important Notice | |||
Important Information Regarding the Year 2000 Transition | HTML | ||
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December 13, 1999 - FDA Public Health Notification | |||
Important Information About Y2K and Medical Devices | HTML | ||
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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 | HTML | DOC | |
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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) | HTML | DOC | |
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November 17, 1999 - Information
for Industry, Healthcare Facilities, and Consumers | |||
Report on the Y2K Readiness Survey of Manufacturers
of Essential Medical Supplies | HTML | DOC | |
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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 | ||
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October 21, 1999 - Congressional Testimony | |||
House Committee on Commerce Subcommittee on Health and Environment and Subcommittee on Oversight and Investigations | HTML | ||
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September 22, 1999 - Y2K Meeting the Challenge | |||
Year 2000 and Medical Devices | HTML | ||
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September 17, 1999 - Information for Healthcare Facilities | |||
User Facility Reporting Bulletin - Summer 1999 | |||
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August 24, 1999 - FDA Talk Paper | |||
The Year 2000 Date Problem and Medical Devices | HTML | ||
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August 24, 1999 - Information for Industry and
Healthcare Facilities | |||
Computer-Controlled
Potentially High-Risk Medical Devices - List of Device Types | HTML | DOC | |
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August 16, 1999 - Federal Register Notice | |||
Agency Emergency Processing Under OMB Review; Survey of Biomedical Equipment Manufacturers | HTML | ||
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August 13, 1999 - Information for Healthcare Facilities and Consumers | |||
Press Release from the President's
Council on Year 2000 Conversion |
An Open Letter | ||
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August
10, 1999 - Information for Industry, Healthcare Facilities, and Consumers
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List of Frequently Asked Questions & Answers | Frequently Asked Questions | ||
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August 5, 1999 - Links to Y2K Related Sites | |||
Global Harmonization Task Force (GHTF) Y2K Presentations | List of Y2K Presentations | ||
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July 30, 1999 - Federal Register Notice | |||
Computer-Controlled Potentially High
Risk Medical Devices-List of Device Types | HTML | ||
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July 16, 1999 - Guidance for Industry and Healthcare
Facilities | |||
MDR Exemption for Y2K Problems | HTML | ||
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July
16, 1999 - Information for Healthcare Facilities | |||
FDA Public Health Notification - Y2K Planning Information | HTML | DOC | |
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June 18, 1999 - Letter to Industry | |||
Y2K
Readiness Survey of Manufacturers of Essential Medical Supplies | Letter and Attachments | ||
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May 10, 1999 - Federal Register Notice | |||
Survey of Medical Device Manufacturers for Year 2000 Compliance of Manufacturing Systems | HTML | ||
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April 26, 1999 - Guidance for Industry | |||
Year 2000 (Y2K) Computer Compliance | HTML | ||
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April 20, 1999 - Congressional Testimony | |||
U.S. Senate - Committee on Veterans' Affairs | HTML | ||
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April
16, 1999 - Guidance for Industry | |||
MDR
Reporting Guidance for Date-Related Problems Including Y2K | HTML | ||
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March 29, 1999 - Letter to Industry | |||
Request for Information on Y2K Compliant Products | Letter and Attachments | ||
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March 3, 1999 - Letter to Industry | |||
Request
for Additional Information on Non-Compliant Products | Letter and Attachments | ||
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