Ann: Proteomics files US FDA 513(g) regulatory submission, page-2

Hi All,

I really wanted to do a little reading before posting my frustration here at this FDA delay.

I suggest you all read the article below before freaking out.

Pre-sub meetings (particularly for IVDs that are directly Non-COVID related) have been affected. It’s out of PIQ’s hands & the timing is disappointing, but I guess there are now millions of new cases being diagnosed everyday with new COVID-19 variants, India alone has hit around 300k new daily cases & thousands of deaths daily, these are only the reported ones.

This has to be put into perspective in a Public Health Emergency & the FDA have a duty of care to review highly urgent medical devices, not just for the USA population, but approval by the FDA will also mean that this may hold in good stead for countries that may not be so rigorous or have the resources to fund comprehensive reviews of COVID-19 related medical devices. The delay is understandable & it actually made me feel sorry for the FDA staff working through weekends & after hours to even get through all of this.

https://www.fda.gov/news-events/fda-voices/year-pandemic-how-fdas-center-devices-and-radiological-health-prioritizing-its-workload-and-looking

The article also gives some timelines. Richard knows what he is doing, & at least we got the ISO13845 for IVD in these trying times with COVID-19, because that is crucial to not only FDA Approval but also moving forward as it is an Internationally recognised Code for Quality Standards for the test.

Look on the bright side, we aren’t dead from SARS-COV2 if you are reading this!

GLTAH