Regulation of Living Organisms
With acceptance of premarket notification 510(k) k033391 in January 2004, the FDA granted Dr. Ronald Sherman permission to produce and market medical maggots for use in humans or other animals as a prescription medical device. Medical maggots represent the first living organism allowed by the Food and Drug Administration for production and marketing as a prescription medical device.
In June 2004, the FDA cleared Hirudo medicinalis (medicinal leeches) as the second living organism to be used as a medical devices.
Read more about this topic: Food And Drug Administration, Regulatory Programs
Famous quotes containing the words regulation of, organisms, regulation and/or living:
“Nothing can be more real, or concern us more, than our own sentiments of pleasure and uneasiness; and if these be favourable to virtue and unfavourable to vice, no more can be requisite to the regulation of our conduct and behavior.”
—David Hume (1711–1776)
“The white man regards the universe as a gigantic machine hurtling through time and space to its final destruction: individuals in it are but tiny organisms with private lives that lead to private deaths: personal power, success and fame are the absolute measures of values, the things to live for. This outlook on life divides the universe into a host of individual little entities which cannot help being in constant conflict thereby hastening the approach of the hour of their final destruction.”
—Policy statement, 1944, of the Youth League of the African National Congress. pt. 2, ch. 4, Fatima Meer, Higher than Hope (1988)
“Nothing can be more real, or concern us more, than our own sentiments of pleasure and uneasiness; and if these be favourable to virtue and unfavourable to vice, no more can be requisite to the regulation of our conduct and behavior.”
—David Hume (1711–1776)
“For to me, living is Christ and dying is gain.”
—Bible: New Testament, Philippians 1:21.