12 Va. Admin. Code § 5-481-350 - Assembler or transfer obligation

Current through Register Vol. 38, No. 3, September 27, 2021

A. Any person who sells, leases, transfers, lends, disposes, assembles, or installs radiation machines or upon significant service or modification thereof of any radiation machine (such as tube inserts, generators, or collimators) in this state shall notify the agency within 15 days of:
1. The name and address of persons who have received these machines;
2. The manufacturer, model, and serial number of each radiation machine transferred; however, in the case of diagnostic x-ray systems that contain certified components, a copy of the assembler's report (Form FDA 2579) prepared in compliance with the requirements of the Food and Drug Administration's Federal Diagnostic X-ray Standard ( 21 CFR 1020.30(d) ) shall be submitted and shall suffice in lieu of any other report by the assembler; and
3. The date of transfer of each radiation machine.
B. No person shall make, sell, lease, transfer, lend, assemble, or install radiation machines or the supplies used in connection with such machines unless such supplies and equipment when properly placed in operation and used shall meet the requirements of these regulations.

Notes

12 Va. Admin. Code § 5-481-350
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; Amended, Virginia Register Volume 31, Issue 24, eff. 8/27/2015.

Statutory Authority: § 32.1-229 of the Code of Virginia.

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