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by generalizations
617 days ago
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> It seems like it's whatever the manufacturer asks for in terms of "intended working life." I would guess the FDA makes their certification easier or harder to pass based on how long the device is expected to last. If the 5 year lifespan is what hits the middle ground for that company between cost-of-certification and useful-product-life, then it's up to the FDA to make a longer lifespan feasible to get certified. |
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