Two Hospitals Pave the Way to Becoming Manufacturers

摘要

Hospitals had until May 18 to register and list with the U.S. Food and Drug Administration (FDA) as manufacturers under the medical device data system (MDDS) rule, but so far only three have done so. The regulation classifies hospitals as manufacturers if they create or drastically change an MDDS, which is designed to send or receive data from a medical device. Two of the three organizations share their experience navigating the process.