21 C.F.R. § 892.5730 Radionuclide brachytherapy source.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart F—Therapeutic Devices
§ 892.5730 Radionuclide brachytherapy source.
