1.
a.
b.
2.
a.
b.
3.
ssembler's Report
assem
ers w
o
ns
a
cer
e
componen
ss
ou
e a repor
o
suc
assem
y.
assembler's reports shall be on Form FD-2579, which is prescribed by and available from
the Director, FDA/Department of Health and Human Services, Division of Compliance,
1390 Piccard Drive, Rockville, Maryland 20850. The original of Form FD-2579 shall be
sent to the Director and copies to the purchaser, State Agency responsible for radiation
rotection
and one ke
t b
the assembler for a
eriod of least 5
ears.
3
The deale
o
distributo
elects to hold and preserve such information, and to immediately
furnish it to MinXray, Inc. when advised by MinXray or Director, Department of Health and
Human Services, that such information is required for purposes of Section 359 of the
Radiation Control for Health and Safet
Act of 1968.
The deale
o
distributor, upon making the election unde
"a" above of this section, promptly
notifies MinXray and the Center for Devices and Radiological Health of such election. Such
notification shall be in writing and shall identify the dealer or distributor and the type of
e
ui
ment for which the information is bein
accumulated.
Records to be furnished to MinXray, Inc. by Dealers and Distributors
The information required in "1" above shall immediately be forwarded to MinXray unless:
2) Identification and brand name of the product.
3) Model number and serial or other identification number of the product.
4) Date of sale, award or lease.
Such information shall include:
1) The name and mailing address of distributor, dealer, or purchaser to whom the product
was transferred.
Dealer and Distributor Records
Dealers and distributors of x-ray equipment shall obtain and preserve fo
a period of five
years from the date of sale, award, or lease of each such product, such information as is
necessar
to
ermit tracin
of s
ecific
roducts to s
ecific
urchasers.
RECORD KEEPING REQUIREMENTS
