Veterinary Medical Devices - FDA Regulations

Veterinary Medical Devices - FDA Regulations

I recently worked on a project that involved writing a regulatory strategy for a device used on animals. This was a new area for me and I got interested in learning even more about the topic afterwards. I was curious as to how big of a market veterinary devices were, as well as what type of regulations were around developing and selling devices for veterinary use.

What I found out about the market was that it is a pretty immature and untapped market. Which is not surprising to me as my first thoughts have always been to develop technologies to improve human health. However it was pretty interesting to think about the way veterinary devices could be developed. Do certain companies develop devices for humans use and then later on change indications for animal use? Or do companies choose to develop technologies to help the animal population right from the beginning?

One appealing piece to the veterinary device market is the fact that there are low regulation barriers to enter the market. I have found that there are fewer requirements about the design of the device when used for animals. There is very little on the FDA website in terms of how the FDA regulates veterinary devices. For example, veterinary devices do not need pre-market approval. Additional veterinary device manufacturers do not need to register themselves or list the devices they distribute. Veterinary device manufacturers are responsible for assuring safety and efficacy of the device as well as proper labeling. The FDA website does say that the FDA has regulatory oversight on veterinary devices but much of the responsibility falls onto the manufacturer.

I'll be interested to see how this market will advance. Will more technologies be developed and used on animals? Will the regulations become more stringent over time as the population grows?

--Jillian F. Walker