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How to Determine if Your Product is a Medical Device FDA

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WebCommercial item means -. (1) Any item, other than real property, that is of a type customarily used by the general public or by non-governmental entities for purposes other than governmental purposes, and -. (i) Has been sold, leased, or licensed to the general public; or. (ii) Has been offered for sale, lease, or license to the general public; WebSep 29, 2024 · The following steps may be helpful when trying to determine if a product is regulated by the FDA as a medical device. Step 1: Determine if your product meets the definition of a medical device per ... WebExamples of essential item in a sentence, how to use it. 19 examples: It is unfortunate that the price might deter some individual purchasers but it should be seen as an… city builder ttrpg