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CondomsareregardedbytheUnitedStatesFoodandDrugAdministration(FDA)as“ClassIImedicaldevices”,thisdesignationalsoincludespregnancytestsand ...
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The U.S. Food and Drug Administration (FDA) examines, tests, and approves a wide range of items for medical use, including drugs and medical appliances. In the simplest terms, “FDA approval” means that the FDA has decided the benefits of the approved item outweigh the potential risks for the items planned use.
The FDA does not develop or test products before approving them. Instead, FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers. If FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the known risks for the intended use.
Source: https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm047470.htm
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【幻象蝴蝶衛生套】許可證字號:衛署醫器輸字第012745號
器材品名:幻象蝴蝶衛生套許可證字號:衛署醫器輸字第012745號註銷狀態:註銷日期:註銷理由:有效日期:2020/10/19發證日期:2005/...