FDA Confirms Intention Not To Enforce Requirements for Medical Device Data Systems
February 10, 2015 at 12:54 PM EST
The FDA Feb. 9 confirmed its intention not to enforce compliance with regulatory requirements for medical device data systems (MDDS) and two similar radiology device types “due to the low risk they pose to patients and the importance they play in advancing digital health.” The confirmation came in final guidance on MDDS issued by the agency’s Center for Devices and Radiologi... Read More
