Form 3541 Premarket Notification [510 ( K )] Status Request and Re

Form Approved: OMB No. 0910-0120; Expiration Date: 5/31/07

Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health

PREMARKET NOTIFICATION [510(K)] STATUS
REQUEST AND RESPONSE

Single Form – To be used for both your request and FDA’s response. Requesters should fill in the information on
the top half of this form (Request Section) and fax (or mail) this form to the FDA at the fax # or address listed below.
The FDA will complete the information on the bottom half (Response Section) and return by fax (or mail).

REQUEST SECTION (To be completed by requester)
To (From)

From (To)

510(k) Status Coordinator
Div. of Small Manufacturers Assistance
FDA, Center for Devices & Radiological Health
5600 Fishers Lane (HFZ-220)

REQUESTER NAME
MAILING ADDRESS

Rockville, MD 20850 USA
Fax Number: (240) 276-3151

FAX NUMBER

Phone: (240) 276-3150 or
(800) 638-2041

TELEPHONE NUMBER
REQUESTER’S AFFILIATION WITH THE SUBMITTER OF
THE 510(K)

Requester Certification: I certify that I am an authorized representative of the submitter of the following 510(k)
and that all information provided herein is truthful to the best of my knowledge. Please provide me with information related to the status of the following 510(k) submission via (mark one): FAX
or MAIL
510(K) NUMBER

REQUESTER SIGNATURE

SPONSOR’S NAME AND ADDRESS

PRODUCT NAME

DATE LOGGED IN BY FDA (ODE) – as identified in
acknowledgement letter

RESPONSE SECTION (To be completed by FDA)
NOTE: THIS DOCUMENT IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED
AND CONTAINS INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER APPLICABLE LAW.
If you are not the addressee, or authorized to deliver this document to the addressee, you are hereby notified that
review, disclosure, dissemination, copying, or other action based on the content of this communication is not
authorized. If document has been received in error, please notify FDA by phone and return via mail.
.
Reviewing Branch:
Please be advised that the average total time (time for FDA review plus
time spent awaiting any additional data) for review of a device assigned to
this branch has been
days over the last 6 months.

LAST ACTION AND DATE

Place in Queue: Your 510(k) has been assigned to a reviewer and is #
in line for that reviewer to work
on. The length of time that it will take for the reviewer to get to your 510(k) and to review it will depend on many
factors, such as the complexity of the 510(k)’s that are in line ahead of you, and other work assigned to the
reviewer, for example the review of investigational device FDA RESPONSE DATE
exemption submissions. Due to these variables, we cannot
estimate a completion date for review of your 510(k).
Please do not request another status report prior to 30 days
However, future inquiries can give you an idea of how your from the FDA response date.
510(k) is progressing.
FORM FDA 3541 (3/07)

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PSC Graphics (301) 443-1090

EF

Public Reporting burden for this collection of information is estimated to average 0.2 hour per response,
including the time for reviewing instructions, searching existing data sources, gathering and maintaining
the data needed, and completing 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:
Food and Drug Administration
CDRH (HFZ-220)
2094 Gaither Road
Rockville, MD 20850

FORM FDA 3541 (3/07)

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