We found our N95 respirator can be registered as FDA product code MSH in FDA database with no 510(k) is needed. Once we got the establishment number issued by FDA, we can only use FDA registered for our N95 respirator. However, why we cannot declare our N95 respirators as FDA cleared? How should we do if we want to be FDA cleared eventually?
here are 2 stories 1) Typical client payout for product liability is 8% 2) not a single lawyer would ever stand up in congress and try to stop any of these products being produced because these injuries produces millions of dollars for this industry every year.
Are there legal limitations on marketing an FDA cleared device? For example, if the device is approved for treating specific diagnoses, what happens if the device is used for treating more diagnoses?
Melinna, good questions. Feel free to reach out through our website contact form at in2being.com for more information, but in short, the intended use of the device and the indications for use as cleared by FDA determine what how the device can be legally marketed. While doctors and patients may decide to use a device "off-label", the marketing company's statements are limited to what claims the device is actually cleared for.
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We found our N95 respirator can be registered as FDA product code MSH in FDA database with no 510(k) is needed. Once we got the establishment number issued by FDA, we can only use FDA registered for our N95 respirator. However, why we cannot declare our N95 respirators as FDA cleared? How should we do if we want to be FDA cleared eventually?
here are 2 stories 1) Typical client payout for product liability is 8% 2) not a single lawyer would ever stand up in congress and try to stop any of these products being produced because these injuries produces millions of dollars for this industry every year.
Are there legal limitations on marketing an FDA cleared device? For example, if the device is approved for treating specific diagnoses, what happens if the device is used for treating more diagnoses?
Melinna, good questions. Feel free to reach out through our website contact form at in2being.com for more information, but in short, the intended use of the device and the indications for use as cleared by FDA determine what how the device can be legally marketed. While doctors and patients may decide to use a device "off-label", the marketing company's statements are limited to what claims the device is actually cleared for.
Emergency Auth?
FDA help American company and push down other , is it normal ???.