Page:United States Statutes at Large Volume 104 Part 6.djvu/122

 104 STAT. 4512 PUBLIC LAW 101-629—NOV. 28, 1990 "(iii) the name and the address of the manufacturer of such device, and "(iv) a brief description of the event reported to the manufacturer. The Secretary may by regulation alter the frequency and timing of reports required by this subparagraph. "(D) For purposes of subparagraphs (A), (B), and (C), a device user facility shall be treated as having received or otherwise become aware of information with respect to a device of that facility when medical personnel who are employed by or otherwise formally affiliated with the facility receive or otherwise become aware of information with respect to that device in the course of their duties. "(2) The Secretary may not disclose the identity of a device user facility which makes a report under paragraph (1) except in connection with— "(A) an action brought to enforce section 301(q), "(B) a communication to a manufacturer of a device which is the subject of a report under paragraph (1), or "(C) a disclosure required under subsection (a). This paragraph does not prohibit the Secretary from disclosing the identity of a device user facility making a report under paragraph (1) or any information in such a report to employees of the Department of Health and Human Services, to the Department of Justice, or to the duly authorized committees and subcommittees of the Congress. "(3) No report made under paragraph (1) by— "(A) a device user facility, "(B) an individual who is employed by or otherwise formally affiliated with such a facility, or "(C) a physician who is not required to make such a report, shall be admissible into evidence or otherwise used in any civil action involving private parties unless the facility, individual, or physician who made the report had knowledge of the falsity of the information contained in the report. "(4) A report made under paragraph (1) does not affect any obligation of a manufacturer who receives the report to file a report as required under subsection (a). "(5) For purposes of this subsection: "(A) The term 'device user facility' means a hospital, ambulatory surgical facility, nursing home, or outpatient treatment facility which is not a physician's office. The Secretary may by regulation include an outpatient diagnostic facility which is not a physician's office in such term. "(B) The terms 'serious illness' and 'serious injury' mean illness or injury, respectively, that— "(i) is life threatening, "(ii) results in permanent impairment of a body function or permanent damage to a body structure, or "(iii) necessitates immediate medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.". 21 USC 360i (b) REGULATIONS. —The Secretary of Health and Human Services shall promulgate regulations to implement section 519(b) of the Federal Food, Drug, and Cosmetic Act, as added by the amendment made by subsection (a) (including a definition of the summary required by paragraph (1)(C) of such section) not later than 12 months after the date of enactment of this Act. In promulgating the note.

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