ARTICLE SUMMARY:
FDA issues new Q-Sub guidance. Excerpted from Pathways’ Picks March 20: Diagnostics Updates, AI Advocacy, China Documents, and More.
FDA details six categories of interactions that device firms can initiate informally without filing an official Pre-Sub in a updated draft of its Q-Submissions program guidance issued March 15. The QSub program includes Pre-Submissions, Submission Issue Requests (SIRS), Study Risk Determinations, Informational Meetings, PMA Day 100 meetings, and other FDA feedback mechanisms. In the latest user fee package (MDUFA V), FDA committed to providing more information about when a company can reach out informally rather than file a Pre-Sub. Administrative questions, teleconferences or emails discussing general FDA policy, and “questions that can be readily answered based on FDA’s reviewer’s experience and knowledge that do not require additional background information, in-depth review, or other FDA staff involvement” are among the interactions that can be handled informally, the draft guidance states. Comments on the draft update are due May 14.