On June 20 the FDA issued a draft guidance essentially deregulating Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Device.
As stated by the FDA, due to the low risk these devices pose to patients and their importance in advancing digital health it does not intend to enforce compliance with the regulatory controls that otherwise would apply, including the Quality System Regulation, establishment registration, and device listing. The draft guidance also proposes conforming edits to the FDA’s 2013 “Mobile Medical Applications” guidance.
