§ 230.3. Definitions.

530 words·~2 min read·/us/cfr/t21/s§ 230.3

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(a)The definitions and interpretations contained in sections 201 and 575 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part.

(b)The following definitions of terms apply to this part:

(1)Adverse event means any untoward medical occurrence associated with the use of a designated medical gas in humans or animals, whether or not it is considered related to the designated medical gas. An adverse event can occur in the course of the use of a designated medical gas; from overdose of a designated medical gas, whether accidental or intentional; from abuse of a designated medical gas; from discontinuation of the designated medical gas (e.g., physiological withdrawal); and it includes any failure of expected pharmacological action.

(2)Applicant means any person who submits a certification request for a designated medical gas under this part, including a supplement, and any person who owns a granted certification for a designated medical gas under this part.

(3)Certification request means a submission under section 576 of the Federal Food, Drug, and Cosmetic Act requesting certification of a medical gas as a designated medical gas.

(4)FDA or Agency means the Food and Drug Administration.

(5)Individual case safety report

(ICSR)means a description of an adverse event related to an individual patient or subject.

(6)ICSR attachments means documents related to the adverse event described in an ICSR, such as medical records, hospital discharge summaries, or other documentation.

(7)Life-threatening adverse event means any adverse event that places the patient, in the view of the initial reporter, at immediate risk of death from the adverse event as it occurred, i.e., it does not include an adverse event that, had it occurred in a more severe form, might have caused death.

(8)Minimum data set for an ICSR for an adverse event means the minimum four elements required for reporting an ICSR of an adverse event: An identifiable patient, an identifiable reporter, a suspect designated medical gas, and an adverse event.

(9)Nonapplicant means any person other than the applicant whose name appears on the label of a designated medical gas container as a manufacturer, packer, or distributor.

(10)Serious adverse event means:

(i)An adverse event is considered “serious” if it results in any of the following outcomes:

(A)Death;

(B)A life-threatening adverse event;

(C)Inpatient hospitalization or prolongation of existing hospitalization;

(D)A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; and/or

(E)A congenital anomaly/birth defect.

(ii)Other events that may be considered serious adverse events: Important medical events that may not result in one of the listed outcomes in this definition may be considered serious adverse events when, based upon appropriate medical judgment, they may jeopardize the patient or study subject and may require medical or surgical intervention to prevent one of the outcomes listed in this paragraph (b)(10). Examples include: Allergic bronchospasm requiring intensive treatment in an emergency department or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of product dependency or product abuse. Additional examples in animals include: Severe hypersensitivity reactions or respiratory distress.