Form Fda 3419 – Fill Out and Use This PDF

Form FDA 3419 is a federal government form used to ensure that manufacturers meet relevant standards, with the ultimate goal of making sure that medical patients receive safe products. By properly filling out the form, manufacturers demonstrate their commitment to providing quality product to consumers and reveal nuances of the device's design process. Furthermore, completing Form FDA 3419 ensures that medical devices reach clinical efficacy and enforceable safety regulations are being adhered to by manufacturers. The form plays a critical role in U.S. Food & Drug Administration departments when they decide to authorize or approve a specific device for market availability and commercial distribution within in the country meaningful use case scenarios.

Form Fda 3419 PDF Details

Form FDA 3419 is a form that pharmaceutical and medical device companies are required to submit to the Food and Drug Administration (FDA) in order to gain approval for their products. The form contains information about the product, such as its composition, how it works, and clinical data. Submission of this form is a critical step in bringing a new product to market. In this blog post, we will discuss what information is required on Form FDA 3419 and how to complete it. We will also provide some tips for submitting your application successfully.

Question	Answer
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)	PAGE 1	(Continue on Page 2, if necessary)	PSC Graphics (301) 443-1090	EF
			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)

PAGE 2

(Continue on a separate sheet, if necessary)

Form Fda 3419 – Fill Out and Use This PDF

Form Fda 3419 PDF Details

Form Preview Example

Form Fda 3419 isn’t the one you’re looking for?

Related Documents