FDA Abandons “Pre-Decisional” IDE Proposal-thegraysheet: FDA has dropped current plans for establishing a specialized interactive review process for investigational device exemption submissions. The agency posted a final guidance on FDA decisions for IDE submissions (PDF) Aug. 18, following up on a June 2013 draft document. In the draft, FDA had proposed a new “pre-decisional” IDE review process, which FDA hoped would help companies maximize the chance of gaining IDE approval for a study that also has a good chance of eventually supporting marketing clearance or approval.
