Page:United States Statutes at Large Volume 90 Part 1.djvu/625

 PUBLIC LAW 94-295—MAY 28, 1976

90 STAT. 575

CONFORMING AMENDMENTS

Amendments to Section 201 SEC. 3. (a)(1)(A) Paragraph (h) of section 201 is amended to read as follows: "(h) The term 'device' (except when used in paragraph (n) of this section and in sections 301(i), 403(f), 502(c), and 602(c)) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessorjr, which is— "(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, "(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or "(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through c'emical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.". (T)) Section 15(d) of the Federal Trade Commission Act is amended (o read as follows: "''d) The term 'device' (except when used in subsection (a) of this section) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is— "(1) recognized in the official National Formulary, or the ITuited States Pharmacopeia, or any supplement to them, "(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or "(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.". (2) Section 201 is amended by adding at the end the following: "(y) The term 'informal hearing' means a hearing which is not subject to section 554, 556, or 557 of title 5 of the United States Code and which provides for the following: "(1) The presiding officer in the hearing shall be designated by the Secretary from officers and employees of the Department of Health, Education, and Welfare who have not participated in any action of the Secretary which is the subject of the hearing and who are not directly responsible to an officer or employee of the Department who has participated in any such action. "(2) Each party to the hearing shall have the right at all times to be advised and accompanied by an attorney. " (3) Before the hearing, each party to the hearing shall be given reasonable notice of the matters to be considered at the Hearing, including a comprehensive statement of the basis for the action taken or proposed by the Secretary which is the subject of the hearing and a general summary of the information which will be presented by the Secretary at the hearing in support of such action.

89-194 O—78—Df 1

40

21 USC 321. "Device." 21 USC 331, 343, 352, 362.

15 USC 55. 'Device.

"Informal hearing."

Notice,

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