Vivos Inc (RDGL)

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CLARIFICATION DIRECT FROM FDA ON 120DAY TIMELINE!!!

Here is my email chain from this morning with a member of the FDA in the DeNovo Submissions Dept. This is DIRECTLY from them but the email chain is too long to screenshot so I put it all here. This should clarify and show that we are STILL waiting. Nothing is wrong, just FDA delays, typical government work... As I have said from DAY ONE, FDA can take the time they want to make a decision, whether or not any follow up questions are asked. See below:

Hello XXXXXX,

I was hoping that I may be able to pick your brain regarding a De Novo submission and how the process is handled. First, I know that the FDA has a timeline of 120 days from submission for the decision, but, I do not see anywhere that specifies if this is 120 business days or 120 calendar days? Also, is this a strict timeline that FDA guarantees to meet unless there are delays for clarification needed? Also, does this 120 days start from the date of submission, or from the date the FDA receives and acknowledges the application submission?

Are you able to offer any update on a submission in process regarding if any delays have come for questions from the FDA to pause a 120 day timeline? The company submission in question is for "Advanced Medical Isotope Corporation" and their "Y-90 Radiogel" product. Any information would be greatly appreciated.

Thank you very much for your consideration and reply and I hope that you have a wonderful day.

------------------------------------REPLY BACK FROM FDA:

Hi XXXXXX,

FDA is directed by statute to reach a decision on a de novo within 120 calendar days of a file being under review by FDA. This 120 day period begins upon the date of receipt by FDA of a de novo submission. Note that this 120 day period does not include time taken by the company to respond to any requests for additional information needed for FDA to reach a decision. There are no MDUFA commitments by FDA associated with these types of submissions.

General questions like these about device regulation should be directed to CDRH's Division of Industry and Consumer Education (DICE). DICE can be reached at [e-mail] or by phone at 1(800) 638-2041 or [phone].

We cannot comment on the status of any submission under review or even if a submission has been made. If you have any such questions, we would recommend you should direct them to the party you believe made a submission.


------------------------------------MY REPLY BACK:

Is the 120 days a hard deadline for a response or is the fda allowed to go beyond that date if no questions are needed to be answered? Thank you for your reply.

------------------------------------ REPLY BACK FROM FDA:

The review of a de novo submission continues until a decision can be reached regardless of the number of days the review has taken.

------------------------------MY REPLY BACK:

Even if there are no questions needed to be answered and therefore no delays in the 129 calendar days, it is still possible for the submission to go beyond that point for a decision to be made? The 120 days is not a set timeline? Thank you for your clarification.

---------------------------------------REPLY BACK FROM FDA:

Yes. If the review is still ongoing by FDA, it is possible for the submission to continue beyond 120 FDA review days.