FDA Approves Swallowed Gadget to Fight Constipation
Published Date: 6/1/2026
Rule
Summary
The FDA is officially putting the new swallowed device for constipation into a safer, easier-to-manage category called Class II. This change helps make sure the device works well and is safe, while also speeding up patient access to this cool innovation by cutting down red tape. The new rules took effect June 1, 2026, and could save companies time and money getting their devices approved.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Faster patient access to new constipation device
You may get access sooner to an orally ingested, electric swallowable capsule for constipation because FDA has classified it as Class II (special controls), which the FDA says will reduce regulatory burdens and enhance patient access. The order is effective June 1, 2026, and FDA notes the classification was applicable on August 26, 2022.
Easier approval path for future device makers
Because FDA classified this device through the De Novo process, the device can serve as a predicate for future devices of the same type, letting future sponsors use the less-burdensome 510(k) pathway instead of a premarket approval application. FDA says this can reduce regulatory burdens and speed patient access.
New testing, labeling, and 510(k) requirements
Manufacturers of this orally ingested transient device must meet Class II special controls and submit a premarket notification (510(k)); required controls include clinical data on treatment and adverse events, dimensional and performance bench testing, leak, bite, pH resistance, bioburden testing, biocompatibility, shelf-life data, software validation, electrical safety and electromagnetic compatibility testing, and specific labeling including a clinical data summary and a shelf life. FDA states it has not exempted this device from 510(k) requirements.
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