Is Your Software A Medical Device? FDA Weighs-in With New Draft Guidances

On December 8, 2017 - nearly a year after President Obama signed into law the 21st Century Cures Act ("Cures Act") - the Food and Drug Administration ("FDA") released two new draft guidances that aim to implement section 3060 of the Cures Act, and provide clarity on the Agency's regulatory approach to software as a medical device. As explained in a statement by FDA Commissioner Scott Gottlieb, the new draft guidances "offer additional clarity about where the FDA sees its role in digital health, and importantly, where we don't see a need for FDA involvement."

Section 3060(a) amended section 520 the Federal Food, Drug, and Cosmetic Act ("FDCA") to remove certain software functions from the definition of device in section 201(h) of the FDCA. The first draft guidance - Clinical and Patient Decision Support Software - focuses on the provision of the Cures Act that exempts certain clinical decision support ("CDS") software from the definition of a medical device. The second guidance - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act - outlines FDA's interpretation of other types of software that are no longer considered medical devices.

Clinical and Patient Decision Support Software

In the first draft guidance, FDA aims to clarify the scope of its regulatory oversight for: (i) CDS software intended for use by health care professionals ("HCPs"); and (ii) patient decision support ("PDS") software intended for use by patients and their caregivers (i.e., non-HCPs). As a reminder, the Cures Act excludes certain CDS software functions from the definition of device, if the software functionalities are:

Not intended to acquire, process, or analyze medical images or signals from an in vitro diagnostic device or from a signal acquisition system (which is defined in the guidance to mean "a signal acquisition system is the electronic circuitry and processor that receives signals from sensors that are within, attached to, or external to the human body"); Intended for displaying, analyzing, or printing medical information about a patient; Intended for supporting or providing recommendations to an HCP about disease treatment, diagnosis, or prevention; and Intended for enabling the HCP to independently review the basis of the recommendations, such that the HCP is not relying primarily on such recommendations to make a clinical diagnosis or treatment decision. FDA broadly defines CDS software to include any...