The Food and Drug Administration (FDA) recently issued a new draft guidance announcing the FDA’s intent to not actively regulate medical device data systems (MDDS), medical image storage devices, and medical image communications devices. This latest development appears to be the next step in the FDA’s overall deregulatory approach for health IT devices and associated software. Once finalized, the guidance, which was issued on June 20, will also have important device tax implications for manufacturers of MDDS and other health IT devices no longer subject to device registration and listing requirements.
More details regarding the draft guidance can be found in an update published by Morgan Lewis’s FDA Practice.