Is a definition for “misadministration” missing from the Final Rule?
No. The term “misadministration” does not appear in the Final Rule and, therefore, no definition is needed. The term “medical event” does appear and is defined. For discussion of replacement of “misadministration” by “medical event” in the Final Rule, refer to “Supplementary Information,” Section III, “Summary of Public Comments and Responses to Comments” for 10 CFR ยง 35.3045, as published in the Federal Register on April 24, 2002.
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