Why do I need to contact the Company? If the clinical data wasn't available before the FDA submission and the Company made the submission with the data they had available then the clinical trial data/results is not relevant or required for the FDA application. I completely trust the Company in its operational execution and am not silly enough to think that I know more than them in the process of Regulatory approval. You still haven't worked out that 510k Application is based on a predicate device that doesn't require current clinical information / data against which to be assessed, that is, it is substantially equivalent to the previous versions.
A 510(k) is a submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims. A legally marketed device is a device that was legally marketed prior to May 28, 1976 (preamendments device), or a device which has been reclassified from Class III to Class II or I, a device which has been found SE through the 510(k) process, or a device that was granted marketing authorization via the De Novo classification process under section 513(f)(2) of the FD&C Act that is not exempt from premarket notification requirements. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate." Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate. Legally marketed also means that the predicate cannot be one that is in violation of the FD&C Act.
RSH Price at posting:
17.0¢ Sentiment: Buy Disclosure: Held
