Public Citizen: FDA's Device Patient Preference Guide Influenced Too Much By Industry

Public Citizen calls for FDA to terminate what the group views as an “inappropriate relationship” with the Medical Device Innovation Consortium and to retract a draft guidance inviting device makers to voluntarily submit scientifically valid patient preference data along with their applications. “Specifically, we write to express our concern that this guidance and other FDA activities related to patient preference information have in effect lowered approval standards for high-risk medical devices, allowing for approval of such devices in cases where...