Page:United States Statutes at Large Volume 111 Part 3.djvu/260

 Ill STAT. 2348 PUBLIC LAW 105-115—NOV. 21, 1997 under paragraphs (1) through (4) to a subset of user facilities that constitutes a representative profile of user reports for device deaths and serious illnesses or serious injuries. "(B) During the period of planning the program under subparagraph (A), paragraphs (1) through (4) continue to apply. "(C) During the period in which the Secretary is providing for a transition to the full implementation of the program, paragraphs (1) through (4) apply except to the extent that the Secretary determines otherwise. "(D) On and after the date on which the program is fully implemented, paragraphs (1) through (4) do not apply to a user facility unless the facility is included in the subset referred to in subparagraph (A), "(E) Not later than 2 years after the date of the enactment of the Food and Drug Administration Modernization Act of 1997, the Secretary shall submit to the Committee on Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report describing the plan developed by the Secretary under subparagraph (A) and the progress that has been made toward the implementation of the plan.". SEC. 214. PRACTICE OF MEDICINE. Chapter IX is amended by adding at the end the following: 21 USC 396. "SEC. 906. PRACTICE OF MEDICINE. "Nothing in this Act shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations. Further, this section shall not change any existing prohibition on the promotion of unapproved uses of legally marketed devices.". SEC. 215. NONINVASIVE BLOOD GLUCOSE METER. (a) FINDINGS. — The Congress finds that^- (1) diabetes and its complications are a leading cause of death by disease in America; (2) diabetes affects approximately 16,000,000 Americans and another 650,000 will be diagnosed in 1997; (3) the total health care-related costs of diabetes total nearly $100,000,000,000 per year; (4) diabetes is a disease that is managed and controlled on a daily basis by the patient; (5) the failure to properly control and manage diabetes results in costly and often fatal complications including but not limited to blindness, coronary artery disease, and kidney failure; (6) blood testing devices are a critical tool for the control and management of diabetes, and existing blood testing devices require repeated piercing of the skin; (7) the pain associated with existing blood testing devices creates a disincentive for people with diabetes to test blood glucose levels, particularly children;

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