According the section 201(h) of the FDA’s Federal Food Drug & Cosmetic (FD&C), a medical device is:
“An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
OK, that’s a mouthful!
That’s from the FDA’s, “Is the Product a Medical Device,” for those who want to learn more. While the language may seem archaic (welcome to the world of medical technology), the distinction is important. “If a product is labeled, promoted or used in a manner that meets the definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA) as a medical device and is subject to premarketing and postmarketing regulatory controls.”
A medical device is not to be confused with pharmaceutical products. “If the primary intended use of a medical product is achieved through chemical action or by being metabolized by the body, the product is usually a drug. Human drugs are regulated by FDA’s Center for Drug Evaluation and Research (CDER).”
The FDA takes its role as a regulator of medical technology very seriously. Products go through rigorous testing and verification before being deemed “safe and effective” (the over-arching criteria) and cleared for sale and use.
The AirAllé medical device for head-lice treatment is just such a device. It is one of the first new medical device-based treatments for head lice to come on the market in many years. It has been through rigorous clinical trials and has been cleared by the FDA as safe and effective for head-lice removal.
Clinical trials on the AirAllé device found that it kills live lice and 99.2 percent of lice eggs (nits). Treatment takes about 90 minutes, and all lice and eggs are killed and removed in a single treatment.
Most other FDA-cleared lice treatments available are pharmaceutical products—chemical, pesticide-based products that must be applied to a person’s head and scalp, after which the lice and eggs must be combed out over several weeks. These treatments don’t kill eggs, and recent studies show that in many countries, including the United States, head lice have developed resistance to the pesticides the products use. The pesticides used in some lice treatment products can be dangerous if not used exactly as directed.
The AirAllé medical device works by applying carefully controlled warm air to the hair and scalp, dehydrating the lice and eggs. There are no pesticides or chemicals involved, and there is no need for repeated combings.
The AirAllé medical device was developed by scientists studying lice at the University of Utah. The clinical trials demonstrating effectiveness were published in the scientific journal Pediatrics and in the Journal of Medical Entomology.
Lice removal using the AirAllé medical device is available exclusively at Lice Clinics of America treatment centers. With more than 100 clinics in the U.S. and clinics in more than 20 countries worldwide, Lice Clinics of America has quickly become the largest network of lice- treatment clinics in the world.