FDA issued a final version of its guidance for “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.” The document is dated February 9, 2015, although it was issued several days prior. This guidance is very significant as it states FDA is exercising discretion and not requiring compliance to the recent regulation for MDDS and goes further to indicate this also applies to Medical Image Management Communication and Storage Devices. The excerpt which indicated this is repeated below and the full guidance is at the link provided.
“This means that for devices that meet the definitions in the regulations listed above, the FDA does not intend to enforce compliance with the regulatory controls, including registration and listing, premarket review, postmarket reporting, and quality system regulation for manufacturers of these types of devices.”