Thursday, August 25, 2005

FDA and Maggots

Is it just me, or do others find it kind of fitting for the FDA to now have to study leeches and maggots, in order to figure out how to regulate their use:
But neither leeches nor maggots have ever been subject to thorough regulation by the Food and Drug Administration. So the medical advisers are being asked to create general guidelines about how they should be safely grown, transported and sold.

Since 1976, the F.D.A. has required that makers of medical devices prove that their products are safe and effective. Those already on the market as of that year had to prove their worth; those invented later had to get approval before marketing.

There are unexplored corners of the nation's medical market, however - no one knows how many, but they are certainly a vanishing few - in which doctors and manufacturers have been doing business since well before 1976 without much notice from the agency. The sale of maggots and leeches is one of those corners.

In addressing it, officials first had to decide which part of the agency had oversight: its biological or device division.

"The primary mode of action for maggots is chewing," said Mark Melkerson, acting director of the Division of General, Restorative and Neurological Devices. "For leeches, it's the eating of blood. Those are mechanical processes." Thus, the agency decided that maggots and leeches were devices, Mr. Melkerson said.


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