Page:United States Statutes at Large Volume 90 Part 1.djvu/631

 PUBLIC LAW 94-295—MAY 28, 1976 name or designation for such device, except that to the extent compliance with the requirements of this subparagraph is impracticable, exemptions shall be established by regulations promulgated by the Secretary.". (4) Such section is amended by adding after subparagraph (3) (as so redesignated) the following: "(4) As used in subparagraph (2), the term 'established name' with respect to a device means (A) the applicable official name of the device designated pursuant to section 508, (B) if there is no such name and such device is an article recognized m an official compendium, then the official title thereof in such compendium, or (C) if neither clause (A) nor clause (B) of this subparagraph applies, then any common or usual name of such device.". (b) Section 508 is amended (1) in subsections (a) and (e) by adding "or device" after "drug" each time it appears; (2) in subsection (b) by adding after "all supplements thereto," the following: "and at such times as he may deem necessary shall cause a review to be made of the official names by which devices are identified in any official compendium (and all supplements thereto)"; (3) in subsection (c)(2) by adding "or device" after "single drug", and by adding "or to two or more devices which are substantially equivalent in design and purpose" after "purity,"; (4) in subsection (c)(3) by adding "or device" after "useful drug", and after "drug or drugs each time it appears; and (5) in subsection (d) by adding "or devices" after "drugs".

90 STAT. 581

"Established name." 21 USC 358.

Review

INSPECTIONS RELATING TO DEVICES

SEC. 6. (a) The second sentence of subsection (a) of section 704 (21 U.S.C. 374) is amended by inserting "or restricted devices" after "prescription drugs" both times it appears. (b) The third sentence of such subsection is amended to read as follows: "No inspection authorized by the preceding sentence shall extend to financial data, sales data other than shipment data, pricing data, personnel data (other than data as to qualifications of technical and professional personnel performing functions subject to this Act), and research data (other than data relating to new drugs, antibiotic drugs, and devices and subject to reporting and inspection under regulations lawfully issued pursuant to section 505(i) or (j), section 507(d) or (g), section 519, or 520(g), and data relating to other drugs or devices which in the case of a new drug would be subject to reporting or inspection under lawful regulations issued pursuant to section 505(j)).". (c)(1) Paragraph (1) of the sixth sentence of such subsection is amended by inserting "or devices" after "drugs" each time it occurs. (2) Paragraph (2) of that sentence is amended by inserting ", or prescribe or use devices, as the case may be," after "administer drugs"; and by inserting ", or manufacture or process devices," after "process drugs". (3) Paragraph (3) of that sentence is amended by inserting "or manufacture or process devices," after "process drugs". (d) Section 704 is amended by adding at the end the following new subsection: "(e) Every person required under section 519 or 520(g) to maintain records and every person who is in charge or custody of such records shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to, and to copy and verify, such records.".

21 USC 355,357. Ante, pp. 564, 565.

Records, accessibility.

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