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Intended use vs. indications for use

Intended use is the broad general purpose of the device; indications for use is the specific disease, condition, or population it's cleared for.

21 CFR 801.4; 21 CFR 814.20(b)(3)(i)
What people get wrong

Intended use decides whether FDA regulates the product at all and shapes the whole regulatory strategy. Indications for use is the narrower, submission-specific statement filed on Form 3881 that defines exactly what you can claim in labeling and marketing once cleared. A device can have one intended use but multiple indications for use across different submissions — expanding indications later usually means a new 510(k), even if the underlying device hasn't changed.

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