FDA
Does my robot need FDA approval?
Only if it's classified as a medical device — surgical robots, exoskeletons for rehab, robots used in diagnosis or treatment. Service robots, cleaning robots, delivery robots, and humanoids for entertainment do NOT need FDA approval. If your robot makes a medical claim, you need FDA 510(k) clearance — which is a 9-12 month process.
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我的机器人需要 FDA 批准吗？
仅当被归类为医疗器械时才需要 — 手术机器人、康复外骨骼、用于诊断或治疗的机器人。服务机器人、清洁机器人、配送机器人和娱乐人形机器人不需要 FDA 批准。如果机器人做医疗声称，则需要 FDA 510(k) 通过 — 是 9-12 个月的流程。
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