Title 21: Food and Drugs
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/ PART 892 - RADIOLOGY DEVICES
/ Subpart F - Therapeutic Devices / § 892.5730 Radionuclide brachytherapy source.
§ 892.5730 Radionuclide brachytherapy source.
(a) Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.
(b) Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.