RE:RE:RE:Believe or Don't 6ixs7eV3nsRoc wrote: if you actually bothered to check the site you would see that HC literally updates the list EVERY WEEKDAY. Under the interim measure HC has greatly expedited the process. 15 days for screening (which is essentially a completeness check) and 25 or 45 days for review (depending on what Class the device is).
I am hopeful but the fact that Safetest is not on the HC list is at the very least concerning
The companys application to Health Canada is not yet listed on the governments site but Peixoto said he could assure it has been done: We submitted our application for Health Canada and we are following their process and approval process. Our team is working with Health Canada to address their follow up questions. Following Health Canada approval, we will take all the necessary steps to ensure we have complied with all provincial and federal guidelines. To get to the final version of the test, we went through a vast number of validations. We also performed an extensive clinical validation (for) accuracy of the test. These clinical studies usually are not published but they are the backbone of our regulatory submissions. All this information was sent with our Health Canada, FDA, ANVISA, and EU submissions. The instructions for use contains the data from the clinical validation, but we can only publish that after Health Canada approval. We are confident that our testing products will meet and exceed all guidelines from Health and Government agencies globally.[/quote]
Source??
I'm not doubting that they submitted the application. I'm just concerned that approval may not be coming. If you think about it, the initial 15 day screening time has already passed and the 10 days to submit the requested information has also passed. If they provided what was requested, the application should already be past screening and under review which means it would be on the list. Remember, screeners don't actually review any of the data, they just make sure all the information is present in order to complete a review. The more I think about it, the more concerning it is that the application is not past screening yet.
Also, I don't really agree with what Camaro said about EU and FDA pulling their approvals because they would have already done their due diligence to make sure their standards are met. Unless HC finds some serious safety/efficacy issue that would trigger notifying these other agencies, those other approvals should stand.