OK, understood. Time is the variable. I'm thinkin
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Posted On: 03/25/2021 7:44:31 AM
OK, understood. Time is the variable.
I'm thinking it's shorter because Mina said this which infers the Innova test meets qualifications.
""Frankly, I don't fully understand the hold up, I've seen the data from these companies," said Mina.
So my reasoning is that the innova test meets technical FDA requirements, but for DIY Home Tests, the additional requirements have to do with increasing the testees ability to successfully self test.
Bella is designed to eliminate problems with DIY testing and get the test results numbers comparable to some degree with administration by medical personnel. I think that is what the FDA wants to see.
The FDA said-
"If a test comes to us with good data, we will authorize it as quickly as our scientific review allows," Caccomo said. "The FDA has and will continue to authorize tests when the data supports authorization. The FDA will not authorize tests where the data is incomplete or does not otherwise support authorization."
My thoughts are that the FDA will not need long to approve a DIY test that shows ease of use, or simple to use Bella AI assistance in step by step instructions.
My two cents.
I'm thinking it's shorter because Mina said this which infers the Innova test meets qualifications.
""Frankly, I don't fully understand the hold up, I've seen the data from these companies," said Mina.
So my reasoning is that the innova test meets technical FDA requirements, but for DIY Home Tests, the additional requirements have to do with increasing the testees ability to successfully self test.
Bella is designed to eliminate problems with DIY testing and get the test results numbers comparable to some degree with administration by medical personnel. I think that is what the FDA wants to see.
The FDA said-
"If a test comes to us with good data, we will authorize it as quickly as our scientific review allows," Caccomo said. "The FDA has and will continue to authorize tests when the data supports authorization. The FDA will not authorize tests where the data is incomplete or does not otherwise support authorization."
My thoughts are that the FDA will not need long to approve a DIY test that shows ease of use, or simple to use Bella AI assistance in step by step instructions.
My two cents.
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