Food and Drug Administration - Regulatory Programs - Regulation of Living Organisms

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

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