Good signs ...., page-1138

The FDA's approval process for animal devices is significantly different from that of human medical devices and drugs. Generally, there is no pre-market approval (PMA) or 510(k) notification required for animal devices. Manufacturers of animal devices do not need to register their establishments or list their devices with the FDA. This means the approval process is usually much shorter and less rigorous than for human-use devices.

• Overall Timeframe:
  Because of the streamlined process, the approval timeframe for animal devices is generally shorter than for human-use devices. There's no set timeframe for "approval" in the same way as with human devices because of the lack of formal pre-market review.

In essence, animal devices are subject to less oversight from the FDA compared to human devices.