Pub. L. 105-115, tit. I, sec. 215
NONINVASIVE BLOOD GLUCOSE METER.
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; 111 STAT. 2349 (8) a safe and effective noninvasive blood glucose meter would likely improve control and management of diabetes by increasing the number of tests conducted by people with diabetes, particularly children; and (9) the Food and Drug Administration is responsible for reviewing all applications for new medical devices in the United States. (b) Sense of Congress.—It is the sense of the Congress that the availability of a safe, effective, noninvasive blood glucose meter would greatly enhance the health and well-being of all people with diabetes across America and the world.