§ 876.5940 Orally ingested transient device for constipation.

(a) Identification. An orally ingested transient device for constipation is an electric swallowable capsule that naturally passes through the gastrointestinal tract for the treatment of constipation. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical data must demonstrate the device performs as intended and evaluate the following: (i) Treatment of constipation; and (ii) All adverse events. (2) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Dimensional testing must verify device dimensions; (ii) Performance bench testing must verify functional aspects of the device design; (iii) Leak testing must verify device integrity under worst case clinical conditions; (iv) Bite testing must demonstrate that the device can withstand bite forces; (v) pH resistance testing must evaluate integrity of the capsule when exposed to a physiological relevant range of pH values; and (vi) Bioburden testing must demonstrate the device does not pose an infection risk throughout the labeled shelf life. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance data must support the shelf life of the device by demonstrating continued package integrity and device functionality over the labeled shelf life. (5) Software validation, verification, and hazard analysis must be performed. (6) Electrical safety and electromagnetic compatibility testing must be performed for any electrical components of the device. (7) Labeling for the device must include: (i) A summary of clinical data for the device, including a discussion of adverse events and clinical benefit; and (ii) A shelf life.