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Regulatory Focus™ > News Articles > Maggots, Leeches and Now Honey—Putative Medical Devices?

Maggots, Leeches and Now Honey—Putative Medical Devices?

Posted 01 January 2008

In a previous article in this magazine, I commented on the astonishing medical device classification and subsequent 510(k) clearances for maggots and leeches.1 Surprises continue to occur as FDA now has recognized honey as a medical device with a legitimate medical use. API-MED, an absorbent dressing containing active manuka honey, was recently cleared and indicated for treating exuding wounds such as diabetic foot and leg ulcers and first- and second-degree partial thickness burns. The labeling makes no mention about antimicrobial effects, although other countries (Canada, Australia, Great Britain and New Zealand) permit that claim.2


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