Form Fda 3419 (3/16) - Medical Device Reporting Annual User Facility Report Form

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

MEDICAL DEVICE REPORTING

OMB: 0910-0437

FOOD AND DRUG ADMINISTRATION

Exp. Date: 12/31/2018

ANNUAL USER FACILITY REPORT

CDRH Medical Device Reporting

P.O. Box 3002

PART 1 - COVER SHEET

Rockville, MD 20847-3002

If MDR reports were not submitted to either the FDA or a device manufacturer during this reporting period, DO NOT submit an

annual report.

PART 1 INSTRUCTIONS

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.

1. REPORT PERIOD

2. USER FACILITY ID (HCFA OR FDA PROVIDED NUMBER)

JAN - DEC

Y Y

3. USER FACILITY INFORMATION

4. USER FACILITY CONTACT INFORMATION

a. Name

b. Street Address

c. City

d. State

e. ZIP Code

c. City

d. State

e. ZIP Code

f. Country/Postal Code (if not U.S.)

g. Telephone Number (Include area code and extension)

(

)

5. TOTAL NUMBER OF REPORTS ATTACHED OR SUMMARIZED

a. Lowest Report Number

(HCFA or FDA Provided No.)

(Year)

(Sequence No.)

b. Highest Report Number

(HCFA or FDA Provided No.)

(Year)

(Sequence No.)

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.

6. SIGNATURE OF CONTACT

7. DATE OF REPORT

M M

D D

Y Y

This section applies only to the requirements of the Paperwork Reduction Act of 1995.

***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***

The public reporting burden time for this collection of information is estimated to average 1 hour per response, including the time to review instructions,

search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this

burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

An agency may not conduct or sponsor, and a person is not

Department of Health and Human Services

required to respond to, a collection of information unless it

Food and Drug Administration

Office of Operations

displays a currently valid OMB control number.

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

FORM FDA 3419 (3/16)

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