The Priority Review

Tag

Medical devices

1 story

  1. Regulation

    FDA draft would require IDE applications for device trials to come in through eSTAR

    An FDA draft guidance of October 28, 2026 would require IDE applications to be electronic submissions built in eSTAR, with no waivers and a transition of at least one year after the final guidance. Comments are due December 28, 2026.

    By Nick Bostic, Editor