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Tag: Intended use

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What's the difference between intended use and indications for use?

3 min read
According to the FDA, a significant number of product recalls are the result of manufacturers' misinterpretations of a product's intended use and indications for use. Understanding **what's the difference between intended use and indications for use?** is therefore not just a matter of semantics but is vital for regulatory compliance, clinical decision-making, and patient safety. Manufacturers, regulators, and healthcare professionals must have a crystal-clear understanding of these distinct concepts.