0543 Fda-3356

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See Reverse for OMB Statement. FORM APPROVED: OMB No. 0910-0469. Expiration Date: July 31, 2007
2. REASON FOR SUBMISSION
VALIDATION--FOR FDA USE ONLY

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1. REGISTRATION NUMBER
(Field Establishment Identifier):

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES,
AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps)

a.

FEI:

(See reverse side for instructions)

PART I - ESTABLISHMENT INFORMATION

PART II - HCT/P INFORMATION

3. OTHER FDA REGISTRATIONS

10. ESTABLISHMENT FUNCTIONS:

a. BLOOD FDA 2830

INITIAL REGISTRATION / LISTING

b.

ANNUAL REGISTRATION / LISTING

c.

CHANGE IN INFORMATION

d.

INACTIVE

NO.

RECOVER

TEST

PROCESS

LABEL

b. DEVICE FDA 2891

NO.

SCREEN

PACKAGE

STORE

DISTRIBUTE

c. DRUG FDA 2656

NO.

11.

TYPES OF
HCT/Ps

4. PHYSICAL LOCATION (Include legal name, number and street, city, state, country, and
post office code)

a. PHONE
5. ENTER CORRECTIONS TO ITEM 4

6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name if applicable,
number and street, city, state, country, and post office code)

a. PHONE
7. ENTER CORRECTIONS TO ITEM 6

8. U.S. AGENT

a. E-MAIL ADDRESS
b. PHONE
9. REPORTING OFFICIAL’S SIGNATURE

a.

Bone

b.

Cartilage

c.

Cornea

d.

Dura Mater

e.

Embryo

f.

Fascia

g.

Heart Valve

h.

Ligament

i.

Oocyte

j.

Pericardium

k.

Peripheral Blood
Stem Cells

l.

Sclera

m.

Semen

n.

Skin

o.

Somatic Cells

p.

Tendon

q.

Umbilical Cord
Blood Stem Cells

r.

Vascular Graft

t.

b. E-MAIL ADDRESS

u.

FORM FDA 3356 (8/04)

HCT/Ps
REGULATED
AS MEDICAL
DEVICES, DRUGS OR
BIOLOGICAL DRUGS

13.

PROPRIETARY NAME(S)

s.

a. TYPED NAME

c. TITLE

12.

HCT/Ps
DESCRIBED IN
21 CFR 1271.10

d. DATE

PREVIOUS EDITION IS OBSOLETE.

v.
PSC Media Arts (301) 443-1090

EF

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INSTRUCTIONS FOR COMPLETING FORM 3356: ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, AND CELLULAR
AND TISSUE-BASED PRODUCTS (HCT/Ps)
Completion of Form FDA 3356 is required under 21 CFR Part 1271, 207.20 and 807.20 for all
establishments engaged in the recovery, processing, storage, labeling, packaging, or distribution of
any HCT/P, or the screening or testing of a cell or tissue donor. After we receive your form, we will
update our records and send a validated form to the reporting official.

Item 9. REPORTING OFFICIAL’S SIGNATURE - The reporting official as listed in Item 6 is the
person appointed by the owner or operator to register the firm and answer all the correspondence
and inquiries relative thereto. The dated signature by the reporting official affirms that all information
contained on the form is true and accurate, to the best of his or her knowledge.

PART I .

PART II.
changed)

ESTABLISHMENT INFORMATION

NOTE: You are required to register and list your HCT/Ps by submitting this form if you recover,
process, store, label, package, or distribute any HCT/P, or screen or test the HCT/P donor unless
one of the following exceptions applies. You are not required to submit this form if:
a. You use HCT/Ps solely for nonclinical scientific or educational purposes,

HCT/P INFORMATION (If Item 2.c is checked, only indicate the information being

Item 10. ESTABLISHMENT FUNCTIONS - Indicate (with an X) the activity(ies) performed by the
registered establishment. Test and screen refer to the donor, not the HCT/P.
Item 11. LISTING FOR HCT/Ps DESCRIBED IN 21 CFR 1271.10 - To list HCT/Ps that are described in 21 CFR 1271.10 (a) indicate (with an X) each HCT/P that fulfills all of the following criteria:

b. You remove and then implant HCT/Ps solely for autologous use during the same
surgical procedure,

a. The HCT/P is minimally manipulated,

c. You are a carrier who accepts, receives, carries, or delivers HCT/Ps in the usual course
of business as a carrier,

b. The HCT/P is intended for homologous use only, as reflected by the labeling, advertising,
or other indications of the manufacturer’s objective intent,

d. You only receive or store HCT/Ps solely for implantation, transplantation, infusion, or
transfer within your facility,

c. The manufacture of the HCT/P does not involve the combination of the cell or tissue
component with a drug or a device, except for a sterilizing, preserving, or storage agent,
if the addition of the agent does not raise new clinical safety concerns with respect to the
HCT/P, and either

e. You only recover reproductive cells or tissue and immediately transfer them into a
sexually intimate partner of the cell or tissue donor, or
f. You are an individual under contract, agreement, or other arrangement with a registered
establishment and only recover and send HCT/Ps to the registered establishment.
Item 3. OTHER FDA REGISTRATIONS - Provide the registration number if your establishment is
already registered with FDA as a Blood, Medical Device or Drug establishment. Your establishment
will not be given a new registration number and you are not required to fill in items 4 to 8 of Part I.
Item 9 must be filled out and signed on all forms. If you choose not to complete, Items 4 to 8 of Part I,
you still must complete and sign Item 9. Then proceed to Part II and provide product information.
Item 4. PHYSICAL LOCATION - Provide the legal name, street address including the postal code
and telephone number of the actual location.
Item 6. MAILING ADDRESS OF THE REPORTING OFFICIAL - Provide the reporting official’s
mailing address including the postal code if it is different from the actual location of the
establishment.
Items 8. U.S. AGENT - Non-U.S. establishments only; Provide your U.S. agent name, institution
name if applicable, street address, e-mail address, and telephone number. United States agent
means a person residing or maintaining a place of business in the United States whom a foreign
establishment designates as its agent.

After completion, return the form to:
Food and Drug Administration
Center for Biologics Evaluation and Research (HFM-775)
1401 Rockville Pike, Rockville, MD 20852-1448
ATTENTION: Tissue Establishment Registration Coordinator
FAX No. (301) 827-2844

FORM FDA 3356 (8/04)

d. The HCT/P does not have a systemic effect and is not dependent upon the metabolic
activity of living cells for its primary function; or the HCT/P has a systemic effect or is
dependent upon the metabolic activity of living cells for its primary function, and (i) is for
autologous use, (ii) is for allogeneic use in a first-degree or second-degree blood relative,
or (iii) is for reproductive use.
If your HCT/P type is not preprinted on the form, list it on lines s-v.
Item 12. HCT/P LISTING FOR MEDICAL DEVICES, DRUGS OR BIOLOGICAL DRUGS - Indicate
(with an X) each HCT/P that is regulated as a drug, device, and/or biological product under the
Federal Food, Drug, and Cosmetic Act and/or section 351 of the Public Health Service Act.
NOTE: For Items 11 and 12, indicate changes to HCT/P listing such as discontinuance (indicate with
a D), or resumption (indicate with an R) of a HCT/P into commercial distribution in June and
December or at the time the change occurs as directed under 21 CFR Part 1271.21. Dates of HCT/P
discontinance / resumption should be provided on an additional page.
Item 13. PROPRIETARY NAMES - Indicate any applicable proprietary names used for the HCT/Ps
listed, such as a trademark.
NOTE: If necessary add an additional page to complete Items 11, 12, or 13.

Public reporting burden for this collection of information is estimated to average .75 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
Center for Biologics Evaluation and Research (HFM-775)
1401 Rockville Pike, Rockville, MD 20852-1448
ATTENTION: Tissue Establishment Registration Coordinator

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.