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€ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Orug Administration

FEB 7 1996 2098 Gaither Road

Rockville MD 20850

Ref:

Dear Submitter:

We appreciate your effort to notify us about new models being
introduced into United States commerce that are subject to
reporting under the Electronic Product Radiation Control
provisions of the Federal Food, Drug, and Cosmetic Act.
However, we no longer require submission of certain types of
reports. Several years ago, the U.S. Office of Management and
Budget directed the Food and Drug Administration to reduce the
reporting and recordkeeping burden on the electronic products
industry. In keeping with that directive, we amended the
regulations in 21 CFR 1002, effective October 19, 1995, to
eliminate some requirements, consolidate others, and Simplify
still others.

Sporadic reports that add new model numbers when there is no
change in radiation emissions or compliance with a performance
standard will no longer be accepted by our agency. These
models should only be reported in annual reports (or quarterly
updates to annual reports) as specified in the amended
regulations and in the revised reporting guides. Therefore,
your document(s) is (are) being returned to you with this
letter.

If you are concerned about documentation for import clearanc
refer to the latest annual report (see enclosed notice date
November 15, 1993). Thank you for your cooperation.

Sincerely yours,

@ ori fai

oanne Barron
Regulatory Operationr
Office of Compliance
Center for Devices
Radiological Hee

Enclosures


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Se. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
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Food and Drug Administration
1390 Piccard Drive

NOV {5 1993 Rockville MD 20850

To: Manufacturers and importers of electronic products
. subject to FDA radiation control performance standards

Subject: Guidance on Importation of Certain Electronic Products

When electronic products subject to performance standards are
imported, Form FD 2877 “Declaration For Products Subject To
Radiation Control Standards" must be completed and submitted with
the import entry papers. One of the requirements for such
products is that they be reported to the Center for Devices and
Radiological Health (CDRH) unless they are exempted from the
standards or the reporting requirements. In the past, guidance
to import officers in the FDA district offices has been to deny
entry to products for which reports had not been submitted.
Therefore, imports officers in the ports of entry have been
requesting the importer to provide the accession number of the
report on the product being imported. The accession number is
then used by the imports officers to query the CDRH computer data
base to verify that the product being imported has been certified
and reported.

However, it.is necessary for information on model numbers to have
been entered in the CDRH computer data base to be available to
the imports officers. Although model numbers have usually been
entered for initial, model change and supplemental reports, the
size of the entry field in the CDRH data base and the resources
available for data entry have always limited the number of model
designations that could be entered under a given accession
number. In particular, long lists of model numbers, such as
appear in some annual reports, cannot be entered. In some cases,
manufacturers have not received the acknowledgement letters
notifying them of the assignment of the accession number at the
time of actual importation. With extremely competitive
industries producing more and more models plus more demands on
CDRH resources this problem has gotten worse. For these reasons,
a search of the data entered for a particular accession number
may not yield the model designation of a particular model that
has been reported.

It is important to note that the accession number assigned to a
report is merely a file point. There is no necessary correlation
between an accession number and the model numbers contained
within the report. Further, if the model is exempted, a report
may not exist for it so that a properly certified product may not
be identified by a unique accession number. All current models
should be reported in the manufacturers’ annual reports but that


Manufacturers and importers of Electronic Products
Page 2

Accession numbers are merely administrative reference numbers
used to facilitate document control at the CDRH. It is not
always possible to correlate an accession number with certain
models of electronic products for which radiation control
performance standards are in effect. The district offices have
been requested to use accession numbers only to verify that the
CDRH did, in fact, assign that number to a report on a similar
regulated electronic product submitted by the manufacturer in
question. The existence of an initial report or a current annual
report should also be sufficient for the release of products
covered by an exemption from continued reporting.

Any questions about this letter should be directed to the
NonMedical Radiological Devices Branch of the CDRH at

(301) 594-4654.

Sincerely yours,

William F. Hooten
Acting Director
Division of Enforcement III
Office of Compliance
Center for Devices

and Radiological Health