Page:United States Statutes at Large Volume 90 Part 1.djvu/615

 PUBLIC LAW 94-295—MAY 28, 1976

90 STAT. 565

" (4) may not require that the identity of any patient be disclosed in records, ref)orts, or information required under this subsection unless required for the medical welfare of an individualj to determine the safety or effectiveness of a device, or to verify a record, report, or information submitted under this Act; and "(5) may not require a manufacturer, importer, or distributor of a class I device to— "(A) maintain for such a device records respecting information not in the possession of the manufacturer, importer, or distributor, or "(B) to submit for such a device to the Secretary any report or information— "(i) not in the possession of the manufacturer, importer, or distributor, or " (ii) on a periodic basis, unless such report or information is necessary to determine if the device should be reclassified or if the device is adulterated or misbranded. In prescribing such regulations, the Secretary shall have due regard for the professional ethics of the medical profession and the interests of patients. The prohibitions of paragraph (4) of this subsection continue to apply to records, reports, and information concerning any individual who has been a patient, irrespective of whether or when he ceases to be a patient. "Persons Exempt

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"(b) Subsection (a) shall not apply to— "(1) any practitioner who is licensed by law to prescribe or administer devices intended for use in humans and who manufactures or imports devices solely for use in the course of his professional practice; "(2) any person wno manufactures or imports devices intended for use in humans solely for such person's use in research or teaching and not for sale (including any person who uses a device under an exemption granted under section 520(g)); and Infra, "(3) any other class of persons as the Secretary may by regulation exempt from subsection (a) upon a finding that compliance with the requirements of such subsection by such class with respect to a device is not necessary to (A) assure that a device is not adulterated or misbranded or (B) otherwise to assure its safety and effectiveness.

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"GENERAL PROVISIONS RESPECTING CONTROL OF DEVICES INTENDED FOR HUMAN USE

"General Rule "SEC. 520. (a) Any requirement authorized by or under section 501, 502, 510, or 519 applicable to a device intended for human use shall apply to such device until the applicability of the requirement to the device has been changed by action taken under section 513, 514, or 515 or under subsection (g) of this section, and any requirement established by or under section 501, 502, 510, or 519 which is inconsistent with a requirement imposed on such device under section 514 or 515 or under subsection (g) of this section shall not apply to such device.

21 USC 360j. 21 USC 351,352, ^^^• Ante, p. 564. Ante, pp. 540, 546, 552.

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