Read e-book online Safety evaluation of medical devices PDF

By Shayne C. Gad

ISBN-10: 0824798279

ISBN-13: 9780824798277

This functional reference examines the results of organic and chemical interactions of scientific units with human tissue -- providing complete assurance at the evaluate of protection in forte units, scientific and surgical provides, imaging structures, in vitro diagnostics, and health and wellbeing info platforms.

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Extra resources for Safety evaluation of medical devices

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S. sales in 1993, but has undoubtedly grown rapidly since then. There are, of course, other ways to categorize medical devices. At a later point in this chapter the regulatory categorizations will be overviewed. II. HISTORY As has previously been reviewed by Hutt (1989), the regulation of medical devices has followed a different history than that of drugs. Medical devices go back to at least the Egyptians and Etruscans. Problems with fraudulent devices in the United States. date back to the late 1700s, though no legislative remedy was attempted until the 1900s.

Regulatory Requirements for Medical Devices: A Workshop Manual, Center for Device and Radiological Health, HHS Publication FDA 92–4165, August 1992. CDRH (1995a). Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, Center for Device and Radiological Health, Food and Drug Administration, Washington, D. C. CDRH (1995b). C. CDRH (1995c). Draft Guidance for the Content of Premarket Notifications for Menstrual Tampons, Center for Device and Radiological Health, Food and Drug Administration, Washington, D.

Connection to another active medical device, as described in rules 2 and 5, will not change the class of an active medical device. Energy supplied in the form of ionizing radiation (rules 6 and 7) is sufficiently covered under rule 10. Because surgically invasive active devices are not intended to be wholly or mainly absorbed by, or chemically changed in, the body (rules 6 and 7), these characteristics were omitted. Devices “intended to administer medicines’’ (rules 6 and 7) are sufficiently covered under rule 11.

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Safety evaluation of medical devices by Shayne C. Gad

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