A licensee may use byproduct material or a radiation source approved for medical use which is not specifically addressed in subparts D through H of this part if—

(a) The applicant or licensee has submitted the information required by §35.12(b) through (d); and

(b) The applicant or licensee has received written approval from the Commission in a license or license amendment and uses the material in accordance with the regulations and specific conditions the Commission considers necessary for the medical use of the material.