US Medical Device Regulation in 1996: Continued Progress
This article was originally published in Clinica
Executive Summary
In 1996, the US FDA's Center for Devices and Radiological Health (CDRH) introduced several initiatives to meet both industry and congressional concerns regarding the delay in the introduction of new medical technologies to the marketplace. Major enforcement and compliance initiatives included the long awaited publication of the new quality system regulation (QSR) on October 7, 1996, and the implementation of the new medical device reporting (MDR) regulation. In addition, Congress finally enacted the FDA Export Reform and Enhancement Act of 1996 to allow easier export of unapproved medical devices, drugs, and biologics.