1. (1) Superficial electronic brachytherapy devices are exempt from the requirements in OAR 333-123-0025 and 333-123-0030.
2. (2) A superficial electronic brachytherapy device shall only be utilized for human use applications specifically approved by the U.S. Food and Drug Administration (FDA) unless participating in a research study approved by the Authority.

3. (3) For the purposes of OAR 333-123-0120 to 333-123-0150, the following definitions apply:

   1. (a) "Personal supervision" means supervision where the supervisor is in the same room as the individual being supervised.
   2. (b) "Direct supervision" means supervision where the supervisor is in the same facility as the individual being supervised.
   3. (c) "General supervision" means supervision where the supervisor is available to the individual being supervised for direct communication either in person, telephone, or other electronic means.

Statutory/Other Authority

ORS 453.605 - 453.807

Statutes/Other Implemented

ORS 453.605 - 453.807

History

PH 72-2020, adopt filed 10/09/2020, effective 10/09/2020