Arrayit Corporation (ARYC)

[MikeCr]

The 10 day period applies to commercial manufacturers not to CLIA labs like Arrayit. The FDA does not object to CLIA labs selling their test if they notify the FDA that they have a validated test.

The FDA does encourage CLIA labs to apply for EUA, but i't not required.

Commercial manufacturers will submit EUA requests, with their validation data, within 10 business days from the date they notified the FDA of their validation testing OR from the date of this policy, whichever is later.