FDA Rescinds Proposed Interpretive Rule On PMA/IDE State Tort Preemption
This article was originally published in The Gray Sheet
Executive Summary
FDA is withdrawing a Dec. 12, 1997 proposed rule stating that investigational device exemption and/or premarket approval application approvals do not preempt state common law claims, a move that eliminates Congressional inquiries on the matter during the FDA commissioner confirmation hearings process for Clinton nominee Jane Henney.