Form FDA 3419 PDF Details

Healthcare facilities and professionals are well-acquainted with the multitude of documents and forms required to maintain compliance with federal regulations, one of which includes the FDA 3419 form. Issued by the Department of Health and Human Services' Food and Drug Administration, this form is a crucial element in the Medical Device Reporting (MDR) process. Annually, user facilities are required to submit a comprehensive report detailing incidents related to medical devices that have had significant adverse effects. The FDA 3419 form serves as a cover sheet and an organizational tool that guides the submission of these critical reports. Designed to streamline the process, the form requires specific information, such as user facility details, contact information, and a summary of events reported throughout the year, if any. Importantly, the directive clarifies that if no MDR reports were filed within the year, submitting an annual report is unnecessary, minimizing unnecessary paperwork. Furthermore, the form stipulates the inclusion of a range of report numbers, attaching a complete copy of Part 2 of the form, or a photocopy of the completed MedWatch FDA Form 3500A for each event reported to the FDA and/or manufacturer. Its structured format aids in ensuring that all pertinent information is provided efficiently and accurately, ultimately aiding the FDA in its mission to protect public health by monitoring medical device performance and responding to potential safety concerns.

QuestionAnswer
Form Name Form FDA 3419
Form Length 2 pages
Fillable? No
Fillable fields 0
Avg. time to fill out 30 sec
Other names fda form 3419 annual user facility report, form fda 3419, fda form 3419, form 3419

Form Preview Example

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

CDRH Medical Device Reporting

P.O. Box 3002

Rockville, MD 20847-3002

MEDICAL DEVICE REPORTING

ANNUAL USER FACILITY REPORT

PART 1 - COVER SHEET

OMB: 0910-0437

Exp. Date: 07/31/2012

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

JAN - DEC

Y Y Y Y

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

3.USER FACILITY INFORMATION

a.Name

b.Street Address

c. City

d. State

e. ZIP Code

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

4.USER FACILITY CONTACT INFORMATION

a.Name

b.Street Address

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 Y Y

Paperwork Reduction Act Statement

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:

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.

FORM FDA 3419 (9/10)

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PSC Graphics (301) 443-1090

EF

 

 

 

MEDICAL DEVICE REPORTING

ANNUAL USER FACILITY REPORT

PART 2 - SUMMARY OF EVENT

PART 2 INSTRUCTIONS

If photocopies of previously submitted FDA Form 3500A (MedWatch) are not provided for each MDR reportable event, complete one copy of the following for each MDR report submitted to FDA and/or the manufacturer during the calendar year covered by this Annual Report.

1. USER FACILITY EVENT REPORT NUMBER

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-

 

 

 

 

 

 

 

-

 

 

 

 

 

 

 

 

 

 

 

 

 

(HCFA or FDA Provided No.)

 

(Year)

 

 

(Sequence No.)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2. WHERE WAS REPORT SUBMITTED? (Check all that apply)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FDA

Manufacturer

 

 

 

 

 

Distributor

 

 

 

 

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3. MANUFACTURER INFORMATION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4. DEVICE INFORMATION

a. Name

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a. Brand Name

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

b. Common Name

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

b. Street Address

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

c. Model Number

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

c. City

 

 

d. State

e. ZIP Code

 

 

 

d. Serial Number

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

e. Lot Number

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

f. Catalog Number

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5. BRIEF DESCRIPTION OF EVENT

FORM FDA 3419 (9/10)

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