Medical Device Reporting Annual User Facility Report FORM FDA 3419 PSC Graphics

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Specifications	Medical Device Reporting Annual User Facility Report FORM FDA 3419 PSC Graphics
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MEDICAL DEVICE REPORTING ANNUAL USER FACILITY REPORT DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CDR

Specifications	Medical Device Reporting Annual User Facility Report FORM FDA 3419 PSC Graphics
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Content	MEDICAL DEVICE REPORTING ANNUAL USER FACILITY REPORT DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CDRH Medical Device Reporting P.O. Box 3002 Rockville, MD 20847-3002 For each report in the range of report numbers listed above, attach a completed copy of Part 2 of this form, or a photocopy of the completed MedWatch FDA Form 3500A for the event that was sent to FDA and/or the manufacturer. In addition, attach a sheet listing report numbers in the above range that are not included in this report and explain why. 1. REPORT PERIOD PART 1 INSTRUCTIONS (Continue on Page 2, if necessary) 4. USER FACILITY CONTACT INFORMATION a. Namea. Name 3. USER FACILITY INFORMATION 6. SIGNATURE OF CONTACT If MDR reports were not submitted to either the FDA or a device manufacturer during this reporting period, DO NOT submit an annual report. 7. DATE OF REPORT a. Lowest Report Number b. Highest Report Number PART 1 - COVER SHEET b. Street Addressb. Street Address f. Country/Postal Code (if not U.S.) c. Cityc. City f. Country/Postal Code (if not U.S.) d. Statee. ZIP Coded. Statee. ZIP Code (HCFA or FDA Provided No.)(Year)(Sequence No.) 2. USER FACILITY ID (HCFA OR FDA PROVIDED NUMBER) 5. TOTAL NUMBER OF REPORTS ATTACHED OR SUMMARIZED M//MDDYYYY FORM FDA 3419 (9/10)PAGE 1 g. Telephone Number (Include area code and extension) ( ) - (HCFA or FDA Provided No.)(Year) - (Sequence No.) Complete one copy of the following information as a cover page for the annual report and return to the address listed above. This report should NOT include reports that are not required but have been submitted voluntarily. - - Public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Paperwork Reduction Act Statement OMB: 0910-0437 Exp. Date: 07/31/2012 JAN - DEC YYYY Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer 1350 Piccard Drive, Room 400 Rockville, MD 20850 An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. PSC Graphics (301) 443-1090 EF
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