FDA classifies swallowable capsule for constipation as a lower-risk medical device
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The Food and Drug Administration has officially classified a new type of medical device into Class II, which is a regulatory category for moderate-risk devices. The device in question is an orally ingested transient capsule designed to treat constipation by passing naturally through the gastrointestinal tract.
Why it matters: This change reduces the regulatory burden for this specific device and any future similar products. Class II devices generally follow a less stringent review path than Class III, which can speed up access for patients while still maintaining safety standards through special controls like testing and labeling requirements.
Who it affects
- Manufacturers of swallowable medical capsules for gastrointestinal conditions
This information comes from a final order published by the FDA in the Federal Register on August 26, 2022; readers should consult the original document for full regulatory text.
Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document