AAEP white paper offers guidance on approval process for medical devices

AAEP white paper offers guidance on approval process for medical devices

May 01, 2011

The American Association of Equine Practitioners (AAEP) released a white paper developed by the Biological and Therapeutic Agents Committee to offer equine practitioners guidance regarding medical devices.

While the document does not address equipment such as syringes, needles and radiographic units, it does focus on devices marketed in the liquid form, for use exclusively within veterinary medicine. Why?

Device advice: AAEP's white paper clarifies many aspects of medical devices in horses, which aren't as regulated as those in people.
AAEP explains, "Understanding the appropriate use of medical devices is important for the treatment of horses in veterinary practices. This paper defines what constitutes a medical device and the associated approval/registration requirements and the use of these products by practitioners in relation to the product label."

This article explores some of the details that are documented within this white paper.

What is a medical device?

Although medical devices are commonly used in both human and veterinary medical practice, there is a distinction for those devices used exclusively within the field of veterinary medicine. That distinction relates to the regulatory oversight of these products.

Differences between human and veterinary medical devices:

  • Device manufacturers who make or distribute devices used exclusively within veterinary medicine are not required to register their establishments or list their devices with the Food and Drug Administration (FDA)-Center for Veterinary Medicine (CVM). (Such registration is required for human devices.)
  • There are no premarket notification requirements. (This notification is required for specific classifications of human devices.)
  • There are no premarket approval requirements. (This approval is required for specific classifications of human devices.)
  • There are no mandatory adverse event reporting requirements. (Adverse event reporting is required for human devices.)
  • There are no registered or approved veterinary medical devices.

A medical device is defined by the FDA in the Food Drug and Cosmetic Act, Section 210 (h) "as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component part or accessory, which is intended for use in the diagnosis, 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 animals and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and it is not dependent upon being metabolized for the achievement of any of its principal intended purposes."

The most important aspect of understanding medical devices for equine practitioners is "an awareness on their part as to what they are using—is it a pharmaceutical or is it a medical device?" says Kenton Morgan, DVM, Dipl. ACT, chair of the AAEP's Biological and Therapeutic Agents Committee.

"First and foremost, whatever we do should be in the best interest and care of the horse. We want to use products that are formulated and developed for the indication of the equine patient. If we're not, we need to be aware of that and understand that we may be taking on some increased liability when we use these products in ways that are not consistent with what they were designed to be used for. And this is especially true if the product is not efficacious or if an unexpected outcome should occur. The primary concern is when we take a medical device and use it as a pharmaceutical."

Medical devices are designed for a specific use. These products may be useful tools to the equine practitioner for those intended purposes. Examples of specific medical device products include a number of hyaluronic acid-containing products and some combination products that have hyaluronic acid, glucosamine and chondroitin sulfate.

They are sold either as topical wound therapies or joint fluid lavage or replacement-type products.