Zdrowie i gospodarka · 17/08/2018

FDA Introduces Voluntary Malfunction Summary Reporting Program for Medical Devices

The US Food and Drug Administration (FDA) is launching a voluntary program allowing medical device manufacturers to report device malfunction medical device reports (MDRs) in summary form on a quarterly basis. This program aims to streamline malfunction reporting, as agreed to in the FDA's 2017 Medical Device User Fee Amendments commitment letter.