The FDA bumped PillCam down to a Class II device with establishment of special controls, lowering the bar for review of the device from the premarket approval pathway to the 510(k) premarket notification pathway. Given Imaging had submitted a petition for the downgrade in November 2012.
Given Imaging’s PillCam is a prescription endoscopic camera designed to be ingested so it can capture imaging of the digestive system as it passes through. The FDA granted Given Imaging approval to sell the device only as a back-up for patients who aren’t able to get a complete colonoscopy through traditional means.
Risks associated with the technology include adverse tissue reactions, failure to excrete the device, equipment malfunction and abdominal pain, nausea, vomiting and choking, the FDA noted. The establishment of special controls, the FDA said, should sufficiently mitigate those risks without the need for more stringent oversight.
Some forms of special controls included bite, pH resistance and shelf-life testing as well image color-performance, electromagnetic compatibility and battery life testing.