10 CFR 35.400, Use of Sources for Manual Brachytherapy
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Manual Brachytherapy
Use of sources for manual brachytherapy
A licensee shall use only brachytherapy sources for therapeutic medical uses:
a
(a) As approved in the Sealed Source and Device Registry; or
b
(b) In research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of § 35.49(a) are met.
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