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Presenter lists required meeting-package contents and timelines for decisions

Agency presentation (regulatory guidance) · July 30, 2026
AI-Generated Content: All content on this page was generated by AI to highlight key points from the meeting. For complete details and context, we recommend watching the full video. so we can fix them.

Summary

The presenter reviewed required meeting‑package elements (product ID, meeting request, development background), warned incomplete packages risk denial, and gave timelines: PDEV decision/denial in about 14 days, typical scheduling ~120 days, pre-submission grant/denial within 30 days and meeting minutes within 30 days of the meeting.

The presenter listed required contents for a formal meeting package: product identification, meeting-request information, development background and sub‑items drawn from the guidance. He warned that "you need to pay attention to this. Otherwise, you may get re denied your requirement will get denied if the package is not complete."

On logistics, the presenter said PDEV meetings are scheduled about 120 days from grant, and that decision or denial notifications for PDEV are typically provided within 14 days. For pre‑submission meetings, the speaker recommended submitting requests "6 to 8 months before anticipate end of submission," and said grants or denial decisions for those requests would be notified within 30 days; official meeting minutes are issued about 30 days after the meeting.