I agree!
I like this portion where it talks about the device being Class II which just means faster approval by the FDA. Also, it looks like nothing was filed with the FDA and won't be until the trials are completed (estimated 4 months from the start of the trials) based on what I'm reading. Is that correct? So once the trials are complete the 501K will be filed and that is when we see something on the clinicaltrials.gov site.
In the United States, medical devices are classified into three different classes, Class I, II and III, on the basis of controls deemed reasonably necessary to ensure the safety and effectiveness of the device. Class I devices are subject to general controls, such as labeling, pre-market notification and adherence to the FDA’s good manufacturing practices, and quality system regulations. Class II devices are subject to general as well as special controls, such as performance standards, post-market surveillance, patient registries and FDA guidelines. Class III devices are those that must receive pre-market approval by the FDA to ensure their safety and effectiveness, such as life-sustaining, life-supporting and implantable devices, or new devices that have been found not to be substantially equivalent to existing legally marketed devices. All of our currently available products are classified as Class II devices.
In the US, our products will require the filing and approval of Form 510K with the FDA. This filing provides evidence for substantial equivalence of the medical device with a previously approved device manufactured by another firm. We plan to conduct clinical trials and then submit the Form 510K. Also, we must contract with a manufacturer that is a capable Class II Medical Device manufacturer and will pass GMP inspections by the agency. Such inspections require compliance with cGMP (current good manufacturing) guidelines that stipulate control of traceable manufacturing procedures, including independence of manufacturing and quality control as well as several other provisions. We intend to begin searching for a manufacturer in January next year with excess capacity in California to comply with all regulations necessary to reach this standard.
