RE:VPT 2025
From the Q3 Review of Dec. 9th:
"In early May we submitted VMS+ v4 to FDA for 510(k) clearance using an expedited process and were advised to resubmit under the standard process due to the novelty of certain product features. This was achieved by the end of that month and we received the review in August. To address several of the questions we elected to engage an external company to conduct cybersecurity testing, and contracted a regulatory consultancy to assist with questions related to AI. Our written follow up is largely complete and we anticipate receiving the additional information within the next 2-3 weeks, following which we will submit the package to FDA. This has taken longer than was originally forecast but we believe that completeness of information is important to the success of the submission."
Is this the normal dragging of the feet at the FDA?