AAEP white paper offers guidance on approval process for medical devices - DVM
News Center
DVM Featuring Information from:


AAEP white paper offers guidance on approval process for medical devices


"Concern arises because it is not uncommon for some of these types of medical device products to be used as pharmaceuticals," says Morgan. "They may have some benefits or they may not. We don't know, because most of them have not been evaluated in that way. The other issue is how they have been manufactured—in an environment that has paid attention to quality control or not. Those are significant issues."

Equine practitioners must understand what they are using and whether or not it has gone through FDA's review, Morgan says. "The labeling looks good, the verbiage may sound similar to that found with a pharmaceutical. Most veterinarians are not aware that there should be an NADA (New Animal Drug Application) or ANADA (Abbreviated New Animal Drug Application) number on the label." Those numbers would indicate that the product is an FDA-approved pioneer drug or an FDA-approved generic drug.

"It is our responsibility as practitioners to know exactly what we are using in our patients," Morgan says.

Safety and efficacy concerns

There is no true category for a veterinary medical device, per se, just medical devices. The general category of medical devices is regulated by the FDA's Center for Devices and Radiological Health (CDRH). There are well-defined processes or requirements to determine the safety, efficacy and registration of these products. However, the safety and efficacy of devices used exclusively within veterinary medicine is a gray area that the FDA-CVM does not currently have a formal review process for.

It all boils down to what is best for the horse. "If some of these devices, which are used as pharmaceuticals, are good and useful, let's get them approved by the FDA-CVM," Morgan says. "With approval comes the assurance that the drugs have been properly evaluated for safety and efficacy and that they are manufactured using very strict quality-control measures."

The future

Will medical devices intended as pharmaceuticals be better-regulated in the future?

"We don't know what the future regulations will be," Morgan says.

"But just within the last 60 days, the FDA-CVM has requested public comment on how to address the prevalence of unapproved animal drug products here in the United States. Although this issue (unapproved animal drugs) is much bigger than just veterinary medical devices, it does apply to devices when they are used as pharmaceuticals. So I think this is very encouraging."

To review the white paper, go to http://aaep.org/.

Kane is a researcher and consultant in animal nutrition. He is an author and educator on nutrition, physiology and veterinary medicine with a background in horses, pets and livestock. He is based in Seattle.


Source: DVM360 MAGAZINE,
Click here