Wearable products (including electronic wristband products that can be used to measure walking distance, calorie consumption, night sleep, vests that can measure electrocardiogram and heart rate), mobile communication devices (such as smartphones) that have medical detection purposes after loading certain software, etc. The momentum of product development is extremely rapid, and this trend has created a new problem for medical device regulatory authorities.
The above products are actually cross-border electronic products. If they are characterized as medical devices, the manufacturer must declare and register with the administrative department in accordance with the regulations, and can only produce and market it after obtaining approval. As the world's largest producer of medical devices, how does the United States manage these cross-border digital electronic medical products?
The author learned from the official website of the US Food and Drug Administration (FDA) that the FDA has adopted an open attitude of "drinking water and raising fish" for the development of some wearable products, smart phones loaded with vital signs software, and other mobile communication products, that is, temporarily not To intervene.
FDA official Bloomberg told the outside world that wearable products such as electronic watches and wristbands, as well as smart phones that can be used to measure vital signs, are digital electronic products with additional special functions. They are currently allowed not to be listed as medical device products.
FDA officials also said that both wearable products and mobile communication electronic products with additional detection functions have not been on the market for a long time, and they still have a long way to go to truly perfect products. At present, FDA does not want to formulate strict regulations to restrict The development of these new concept products. However, this decision does not mean that the manufacturers of the above products can arbitrarily exaggerate the functions of the products to mislead consumers. Once the FDA market inspector finds that there is exaggerated publicity, it will immediately stop it.
According to Bloomberg, the FDA has handled two incidents involving smartphone manufacturers misleading consumers by publishing false advertisements. Among them, a smartphone manufacturer advertised in the media that as long as users use the smartphone to scan the skin, they can know whether they have melanoma (the incidence of such cancers is higher in European and American countries). This is obviously an exaggerated advertising misleading behavior. So far, no medical product in the world has this function. After discovering the wrongdoing, FDA ordered manufacturers to stop advertising and impose corresponding fines. The other company investigated was also a smartphone manufacturer. The company advertised that its smartphone was "the only smartphone that can be used to scan the skin for melanoma and other skin diseases" on the US market. This "cowhide advertisement" was also severely investigated by the FDA.
FDA officials said that despite the fact that individual manufacturers illegally advertised that their smartphones have medical device uses, the vast majority of wearable product manufacturers and smartphone manufacturers in the United States still abide by the law. In order to promote the development of the US smartphone industry and wearable products, FDA will not introduce strict regulatory measures at this stage.
The above products are actually cross-border electronic products. If they are characterized as medical devices, the manufacturer must declare and register with the administrative department in accordance with the regulations, and can only produce and market it after obtaining approval. As the world's largest producer of medical devices, how does the United States manage these cross-border digital electronic medical products?
The author learned from the official website of the US Food and Drug Administration (FDA) that the FDA has adopted an open attitude of "drinking water and raising fish" for the development of some wearable products, smart phones loaded with vital signs software, and other mobile communication products, that is, temporarily not To intervene.
FDA official Bloomberg told the outside world that wearable products such as electronic watches and wristbands, as well as smart phones that can be used to measure vital signs, are digital electronic products with additional special functions. They are currently allowed not to be listed as medical device products.
FDA officials also said that both wearable products and mobile communication electronic products with additional detection functions have not been on the market for a long time, and they still have a long way to go to truly perfect products. At present, FDA does not want to formulate strict regulations to restrict The development of these new concept products. However, this decision does not mean that the manufacturers of the above products can arbitrarily exaggerate the functions of the products to mislead consumers. Once the FDA market inspector finds that there is exaggerated publicity, it will immediately stop it.
According to Bloomberg, the FDA has handled two incidents involving smartphone manufacturers misleading consumers by publishing false advertisements. Among them, a smartphone manufacturer advertised in the media that as long as users use the smartphone to scan the skin, they can know whether they have melanoma (the incidence of such cancers is higher in European and American countries). This is obviously an exaggerated advertising misleading behavior. So far, no medical product in the world has this function. After discovering the wrongdoing, FDA ordered manufacturers to stop advertising and impose corresponding fines. The other company investigated was also a smartphone manufacturer. The company advertised that its smartphone was "the only smartphone that can be used to scan the skin for melanoma and other skin diseases" on the US market. This "cowhide advertisement" was also severely investigated by the FDA.
FDA officials said that despite the fact that individual manufacturers illegally advertised that their smartphones have medical device uses, the vast majority of wearable product manufacturers and smartphone manufacturers in the United States still abide by the law. In order to promote the development of the US smartphone industry and wearable products, FDA will not introduce strict regulatory measures at this stage.