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4731.4450 USE OF BRACHYTHERAPY SOURCES.

A licensee must use only brachytherapy sources for therapeutic medical uses:

A.

as approved in the sealed source and device registry; or

B.

in research, according to an active investigational device exemption application accepted by the Food and Drug Administration, provided the requirements of part 4731.4410, item A, are met.

Statutory Authority:

MS s 144.1202; 144.1203

History:

29 SR 755

Published Electronically:

March 12, 2009

Official Publication of the State of Minnesota
Revisor of Statutes