FDA Establishing PMA/PDP Bioresearch Monitoring Review SOPs Via Guidance
This article was originally published in The Gray Sheet
Executive Summary
FDA's Office of Device Evaluation may withhold final action on a premarket approval application or product development protocol if a bioresearch monitoring audit has revealed a "serious problem which impacts on the evaluation of the safety and effectiveness of the device," the agency's recently released guidance on bioresearch monitoring in the PMA/PDP process states.