Link to an amendment published at 83 FR 33110, July 16, 2018.

A licensee shall use sealed sources in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units for therapeutic medical uses:

1. (a) As approved in the Sealed Source and Device Registry; or
2. (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.