Page:United States Statutes at Large Volume 104 Part 6.djvu/121

 PUBLIC LAW 101-629—NOV. 28, 1990 104 STAT. 4511 Public Law 101-629 101st Congress An Act To amend the Federal Food, Drug, and C!osmetic Act to make improvements in the regulation of medical devices, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE AND REFERENCE TO ACT. (a) SHORT TITLE. —T h is Act may be cited as the "Safe Medical Devices Act of 1990". 0?) REFERENCE.—Whenever in this Act (other than in section 19) an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act. SEC. 2. USER REPORTS. (a) REQUIREMENT.—Section 519 (21 U.S.C. 360i) is amended by redesignating subsection (b) as subsection (c) and by inserting after subsection (a) the following: "User Reports "(b)(1)(A) Whenever a device user facility receives or otherwise becomes aware of information that reasonably suggests that there is a probability that a device has caused or contributed to the death of a patient of the facility, the facility shall, as soon as practicable but not later than 10 working days after becoming aware of the information, report the information to the Secretary and, if the identity of the manufacturer is known, to the manufacturer of the device. In the case of deaths, the Secretary may by regulation prescribe a shorter period for the reporting of such information. "(B) Whenever a device user facility receives or otherwise becomes aware of information that reasonably suggests that there is a probability that a device has caused or contributed to the serious illness of, or serious injury to, a patient of the facility, the facility shall, as soon as practicable but not later than 10 working days after becoming aware of the information, report the information to the manufacturer of the device or to the Secretary if the identity of the manufacturer is not known. "(C) Each device user facility shall submit to the Secretary on a semi-annual basis a summary of the reports made under subparagraphs (A) and (B). Such summary shall be submitted on January 1 and July 1 of each year. The summary shall be in such form and contain such information from such reports as the Secretary may require and shall include— "(i) sufficient information to identify the facility which made the reports for which the summary is submitted, "(ii) in the case of any product which was the subject of a report, the product name, serial number, and model number. Nov. 28, 1990 [H.R. 3095] Safe Medical Devices Act of 1990. Health care. 21 USC 301 note.

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