(a) Identification. An ingestible gastrointestinal blood detection capsule device is a prescription device that uses spectrophotometry (light absorption technology) to detect the presence or absence of blood in the gastrointestinal tract.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. Testing must evaluate:

(i) Detection of presence or absence of blood when compared to endoscopic procedures used to detect upper gastrointestinal bleeding;

(ii) Capsule excretion and recovery; and

(iii) All adverse events.

(2) Non-clinical performance testing must demonstrate 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 testing must verify functional aspects of the device design;

(iii) Battery life testing must be performed to demonstrate the capsule's operating time is not constrained by the battery capacity;

(iv) Leak testing must verify device integrity under worst-case clinical conditions;

(v) Bite testing must demonstrate that the device can withstand bite forces;

(vi) pH resistance testing must evaluate integrity of the capsule when exposed to a physiological relevant range of pH values;

(vii) Control and monitoring of capsule bioburden must demonstrate the device does not pose an infection risk; and

(viii) Blood detection testing must demonstrate that the device can detect different forms of blood seen under anticipated conditions of use.

(3) Software validation, verification, and hazard analysis must be performed.

(4) Electrical safety, thermal safety, mechanical safety, and electromagnetic compatibility testing must be performed.

(5) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.

(6) The patient-contacting components of the device must be demonstrated to be biocompatible.

(7) Performance testing must support the shelf life of the device by demonstrating continued package integrity and device functionality over the identified shelf life.

(8) Physician labeling must include:

(i) A detailed summary of the clinical testing pertinent to use of the device, including information on effectiveness and device- and procedure-related complications;

(ii) Warning that the device is not a standalone diagnostic device and does not replace clinical decision making; and

(iii) A shelf life.

(9) Patient labeling must include:

(i) An explanation of the device and the mechanism of operation;

(ii) The patient preparation procedure;

(iii) A brief summary of the clinical study; and

(iv) A summary of the device- and procedure-related complications pertinent to use of the device.

[91 FR 36521, June 17, 2026]