RECORD KEEPING REQUIREMENTS
1. Dealer and Distributor Records
a. Dealers and distributors of x-ray equipment shall obtain and preserve for a period of five years
from the date of sale, award, or lease of each such product, such information as is necessary to
permit tracing of specific products to specific purchasers.
b. Such information shall include:
1) The name and mailing address of distributor, dealer, or purchaser to whom the product was
transferred.
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.
2. Records to be furnished to MinXray, Inc. by Dealers and Distributors
The information required in "1" above shall immediately be forwarded to MinXray unless:
a. The dealer or distributor 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 Safety Act of 1968.
b. The dealer or distributor, upon making the election under "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 equipment
for which the information is being accumulated.
3. Assembler's Report
All assemblers who install certified components should file a report of such assembly. All
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 protection, and one kept by
the assembler for a period of least 5 years.
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