Vivos Inc (RDGL)

[mikepgator]

You’re saying the 30 day window started on 6/28 but I’m saying it started sometime between 6/28 and 7/9, that is all I’m saying, and I am 100% not wrong. And I’m pretty sure you are not right.

If you look at the FDA website, it looks like there could even be something that needs to be physically mailed. (may or may not apply here, didn’t really look too much into this)

For most devices, you must mail the Company Cover Letter and valid eCopy to CDRH’s or CBER’s Document Control Center (DCC). The current mailing address for CDRH’s DCC and a link to CBER’s DCC’s mailing address are provided on the eCopy Program for Medical Device Submissions webpage.

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-application#addfor