What section of Part 35 applies to the use and calibration of Low Dose Rate (LDR) therapy devices?
Subpart H, “Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units,” governs, unless the device employs a remote beta-emitting radioisotope or is not remotely driven. In these cases, § 35.1000, “Other Medical Uses of Byproduct Material or Radiation From Byproduct Material,” is the appropriate section for remote beta-emitting sources and 35.400 is the appropriate section for manual LDR sources. Refer to “Supplementary Information,” Section III, “Summary of Public Comments and Responses to Comments” for 10 CFR § 35.615, as published in the Federal Register on April 24, 2002.
