Zdrowie i gospodarka · 14.02.2014
Questions and Answers About Electronic Medical Device Reporting; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Questions and Answers About eMDR--Electronic Medical Device Reporting." FDA has published a final rule that requires device manufacturers and importers to submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs), to the Agency in an electronic format that FDA can process, review and archive. This guidance provides general information regarding how to prepare and send an electronic postmarket medical device report to the Center for Devices and Radiological Health (CDRH) in FDA. The guidance also identifies where to find more detailed information on the preparation and transmission of the reports.