December 13, 2017
Authored and Edited by Scott A. Allen; Susan Y. Tull
Due to the increasing use of software in medical devices and support services, FDA recently issued draft Guidance to provide clarity on the scope of its oversight over clinical decision support software intended for healthcare professionals versus support software intended for patients and caregivers. In the Guidance, FDA provides examples of software functionalities that meet the definition of a regulated “device” under the Section 3060(a) of the 21st Century Cures Act, as well as software functionalities that may meet the definition of “device” but will not be enforced by FDA.
In order to provide a full understanding of FDA’s intentions, the Guidance first explains FDA’s interpretation of the four elements for determining what support software is excluded from its regulatory oversight under Section 520(o)(1)(E) of the FDCA, as implemented by the Cures Act. These concise interpretations inform and provide a rationale for a detailed set of example software functions that are excluded from FDA regulatory oversight and software functions that remain as regulated devices.
The examples of software excluded from FDA oversight focus on functionality that assists healthcare professionals in making independent medical decisions, including software that:
Examples of software that remains subject to FDA oversight include, for instance, many software functionalities that recommend or create patient-specific treatment plans or diagnoses:
Importantly, the Guidance sets forth FDA’s policy regarding patient decision support software, which is not technically excluded under the language of Section 520(o)(1)(E) of the FDCA. The Guidance states that FDA intends to adopt an enforcement discretion policy for patient decision support software that generally mirrors the same policy outlined for clinical decision support software for healthcare professionals. The Guidance provides a summary for how patient decision support software would be excluded from regulatory oversight under the same criteria used for healthcare professionals. Moreover, the Guidance provides several detailed examples of such software that will and will not fall within FDA’s intended regulatory purview.
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