Do medical events only apply to uses of byproduct material that require a written directive?
No. “Medical event” means an event that meets the criteria in § 35.3045(a). However, because these reporting criteria include dose-based thresholds, it is unlikely that a medical event would be associated with a medical use that does not require a written directive. Refer to “Supplementary Information,” Section III, “Summary of Public Comments and Responses to Comments” for 10 CFR § 35.3045, as published in the Federal Register on April 24, 2002.