10 C.F.R. § 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.
Title 10 - Energy
A licensee shall use sealed sources in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units for therapeutic medical uses: (a) As approved in the Sealed Source and Device Registry; or (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.
Title 10: Energy
PART 35—MEDICAL USE OF BYPRODUCT MATERIAL
Subpart H—Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units
§ 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.
