2767 Notice of Availability-Sample electronic Product

Reporting and Recordkeeping for Electronic Products - General Requirements

06_FDA_Form_2767_Notice_Availability_Sample_Electronic_Product

Reporting and Recordkeeping for Electronic Products - General Requirements

OMB: 0910-0025

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Form Approved: OMB No. 0910-0025
Expiration Date: December 31, 2006

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DATE

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

NOTICE OF AVAILABILITY OF SAMPLE ELECTRONIC PRODUCT
NOTE: This report is authorized by Public Law 90-602 for radiation-emitting products.

Paperwork Reduction Act Statement
Public reporting burden for this collection of information is estimated to average .08 hours per response, including the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data needed, 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:
Food and Drug Administration
CDRH (HFZ-342)
2094 Gaither Road
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."
Please DO NOT RETURN this application to this address.

The ________________________________________________ agrees to provide, on a loan basis and
for a period of three to six months, the model(s) listed below for the purposes of compliance testing to
the applicable FDA standard or in the case of medical devices, the applicable voluntary standard(s)
specified in the attached letter. It is our understanding that the product(s) will only be subjected to
nondestructive testing and that FDA will reimburse us for any costs of damaged parts.
1. MANUFACTURER

2. PRODUCT (i.e., TV, Microwave Oven, Medical Device, etc.)

3. BRAND

4. MODEL

5. CHASSIS SERIES

a. Product

b. Service Manual

6. DATES OF AVAILABILITY:
7. COMMENTS

8.

PERSON(S) TO CONTACT REGARDING SAMPLE
LOCATION A

LOCATION B

Name and Title

Name and Title

Street Address

Street Address

City, State, ZIP Code

Area Code / Telephone No.

9.

City, State, ZIP Code

Area Code / Telephone No.

LOCATION(S) TO WHICH SAMPLE(S) SHOULD BE RETURNED
LOCATION B

LOCATION A

10.

NAME(S) OF PERSON(S) AUTHORIZING LOAN
LOCATION A

Name and Title

RETURN
TO:

LOCATION B
Name and Title

FOOD AND DRUG ADMINISTRATION
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (HFZ-342)
2094 GAITHER ROAD
ROCKVILLE, MD 20850

FORM FDA 2767 (12/03)

PREVIOUS EDITION IS OBSOLETE

PSC Media Arts (301) 443-1090

EF


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File Modified2006-11-07
File Created2003-12-29

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