Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies.

Abstract

Postmarketing surveillance is critical to evaluating the safety and effectiveness of medical devices. The US Food and Drug Administration (FDA) may order the manufacturer of a high-risk device to conduct postmarketing surveillance studies, known as postapproval studies (PASs), at the time of approval. To understand the characteristics of PASs ordered in recent years and inform discussions about the direction of the PASs program. Descriptive study of the PASs ordered for medical devices using the