Vivos Inc (RDGL): What can I expect from the FDA if Breakt...

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Tuesday, 12/26/2023 1:07:41 PM

Tuesday, December 26, 2023 1:07:41 PM

What can I expect from the FDA if Breakthrough Device designation is granted?
If your device is granted the Breakthrough Device designation, you can choose to interact with the FDA to obtain feedback on your device development through a variety of options including:

- sprint discussions,
- request for discussion on a data development plan, and
- request for clinical protocol agreement.

You will ALSO RECEIVE PRIORITIZED REVIEW ON future regulatory submissions for the device, including Q-Submissions, INVESTIGATIONAL DEVICE EXEMPTION (IDE) applications, and marketing submissions.

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Recent RDGL News

Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/13/2024 05:58:27 PM
Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/13/2024 05:56:22 PM
Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/07/2024 05:26:33 PM
Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/02/2024 01:00:03 PM
Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/29/2024 05:16:12 PM
Form QUALIF - Notice of Qualification [Regulation A] • Edgar (US Regulatory) • 07/17/2024 04:15:04 AM
Form 1-A/A - Offering Statement [Regulation A]: [Amend] • Edgar (US Regulatory) • 07/15/2024 10:02:55 AM
Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/04/2024 06:28:50 PM
Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 09:30:31 PM
Form 8-K - Current report • Edgar (US Regulatory) • 12/27/2023 09:40:48 PM
Form 1-A POS - • Edgar (US Regulatory) • 11/27/2023 10:29:12 PM
Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/06/2023 04:28:46 PM
Form 1-A POS - • Edgar (US Regulatory) • 11/03/2023 09:03:20 PM
Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/19/2023 04:18:34 PM
Form 8-K - Current report • Edgar (US Regulatory) • 10/11/2023 10:33:58 AM
Form 1-A POS - • Edgar (US Regulatory) • 10/10/2023 04:05:36 PM

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