Letters to Industry - March 29, 1999 Letter and Attachments (CDRH)

Letters to Industry - March 29, 1999 Letter and Attachments (CDRH)

These documents are available in one or more of the following file formats: Adobe Acrobat (PDF), Microsoft Word 97 (DOC), Microsoft Excel 97 & 5.0/95 (XLS), and/or HTML-text. By following these simple instructions you will be on your way:

Click on the appropriate document file format link(s) in which you are interested. For PDF formats, you should be using the Adobe Acrobat Reader 3.x or greater. Click here to download the Acrobat Reader. For PDF, DOC, and XLS formats, follow your browser's instructions for downloading and/or viewing the selected document. Follow the instructions on each form for completing and submitting the information. Duplicate and distribute the forms as appropriate. If you have any questions about completing the forms or about the Federal Y2K Biomedical Equipment Clearinghouse please E-Mail us at y2k@cdrh.fda.gov.
Letter to Biomedical Equipment Manufacturer	PDF	DOC	HTML

Instructions and Information Regarding Submission of Updated Year 2000 Status Information for Compliant Products	PDF	DOC	HTML

List of Product Classification Names	PDF	DOC	HTML

Options for Reporting	PDF	DOC	HTML

E-File Reporting Template	XLS

E-File Reporting Format Instructions	PDF	DOC	HTML

FORM FDA 3472 - History Form	PDF	DOC

FORM FDA 3473 - Additional Information Request Form Manufacturer Reporting Y2K Compliant Products	PDF	DOC

FORM FDA 3474 - Compliant Products	PDF	DOC