This is why the stop occurred. The product is al
Post# of 22465
(Total Views: 659)
Posted On: 06/11/2021 10:11:25 AM
This is why the stop occurred.
In order for any "Manufacturer" or "Re-Manufacturer" of any device for medical use in the United States, must submit an application ("510-K"
to the FDA for license to manufacture, sell and distribute the product.
My guess, is one of the companies that Innova acquired had not submitted the "510-K". Innova can submit a request for EUA while the application for the 510-K is submitted and under review. Most other manufactur's for this Covid-19 are using the "EUA" (Emergency Use Authorization" all of the "Vaccines" are only authorized by the FDA "NOT APPROVED"
The following quote by the FDA in their letter,
It is not the end of the world. My personal experience , I was a Field Engineer on a 510-K performing data collection, calibration and documenting repairs for the first "Full Field Digital Mammography Unit" with GE Healthcare for 2 years. there were 3 of us, one field engineer before and one after me..
The bottom line, someone did not submit their 510-K. I worked with 2 Medical Physicist's on "False Positive and False Negative" reporting requirements.
Regards
Sunny:>))
Quote:
The product is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k
In order for any "Manufacturer" or "Re-Manufacturer" of any device for medical use in the United States, must submit an application ("510-K"
to the FDA for license to manufacture, sell and distribute the product. My guess, is one of the companies that Innova acquired had not submitted the "510-K". Innova can submit a request for EUA while the application for the 510-K is submitted and under review. Most other manufactur's for this Covid-19 are using the "EUA" (Emergency Use Authorization" all of the "Vaccines" are only authorized by the FDA "NOT APPROVED"
The following quote by the FDA in their letter,
Quote:which is key. One has to only look at the Vaccine injury report
To date, the FDA has not received reports of injuries or death associated with use of the Innova SARS-CoV-2 Antigen Rapid Qualitative Test.
Quote:
About VAERS
Healthcare professionals are required to report certain adverse events..
It is not the end of the world. My personal experience , I was a Field Engineer on a 510-K performing data collection, calibration and documenting repairs for the first "Full Field Digital Mammography Unit" with GE Healthcare for 2 years. there were 3 of us, one field engineer before and one after me..
The bottom line, someone did not submit their 510-K. I worked with 2 Medical Physicist's on "False Positive and False Negative" reporting requirements.
Regards
Sunny:>
))
(2)
(0)