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• W2016154243 abstract "The Development of medical devices for the screening, diagnosis, treatment, and care of patients is a large industry, currently with more than 1800 types of products and 60,000 to 80,000 brands and models. 1 Personal communication. Division of Small Manufacturing, Food and Drug Administration, 1997. Google Scholar Medical devices play a very important role in medical care, and the growth seems likely to continue as technology is applied to medicine. Research and development of medical devices is conducted by both large and small companies even though the cost of bringing a device to the market can be substantial. In 1980, there were 6500 device companies, but by 1995, this number had grown to more than 22,000. More than half of these companies have less than 100 employees. Part of the development process requires approval by the Center for Devices and Radiological Health at the Food and Drug Administration (FDA). The standards that the review process requires for device approval have been under review and modification (Temple Report). 2 Final Report of the Committee for Clinical Review (Based on a review of selected medical device applications). Food and Drug Administration, March 1993 Google Scholar The report calls for device evaluation standards that would be similar to standards for drug approval. To minimize the time and cost of research and development, intermediate or surrogate outcome measures have been widely used for drugs, for biologics, and for devices. A surrogate outcome is a laboratory or biologic measure that is used as a substitute for a clinically meaningful and relevant outcome. While the clinical outcome directly measures how a patient feels or survives, the surrogate has no direct value to the patient." @default.
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• W2016154243 title "The role of surrogate outcome measures in evaluating medical devices" @default.
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