FDA 3541 Premarket Notification [510(K)] Status Request and Respo

Form Approved: OMB No. 0910-0120; Expiration Date: XX/XX/XXXX

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)

FDA, Center for Devices & Radiological Health
Division of Small Manufacturers, International
and Consumer Assistance (DSMICA)
Attn: 510(k) Status Coordinator
10903 New Hampshire Avenue
WO66-4613
Silver Spring, MD 20993 USA

REQUESTER NAME
MAILING ADDRESS

FAX NUMBER

Fax Number: (301) 847-8149
Phone: (301) 796-7100 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. Because of these variables, we
cannot estimate a completion date for review of your 510(k).
However, future inquiries can give you an idea of how your Please do not request another status report prior to 30 days
from the FDA response date.
510(k) is progressing.
FORM FDA 3541 (04/17)

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PSC Graphics (301) 443-6740

EF

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Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

FORM FDA 3541 (04/17)

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