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Alexander Gaffney Senior Manager, Health Research Institute, PwC US October 11, 2019


Developers of clinical decision support (CDS) software, which uses clinical data to offer treatment recommendations, likely will benefit from the release of FDA guidance outlining which products require regulatory review and which are exempt from some regulatory requirements.

The FDA generally has considered CDS software as medical devices, but the products have existed in something of a regulatory gray area. Amendments to Section 520(o)(1)(E) of the FD&C Act made by the 21st Century Cures Act outlined four criteria for exemption from the FDA’s definition of a medical device and the regulatory requirements that go with it.

According to the guidance, CDS software is not a medical device if it is:

  1. “Not intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system;
  2. “Intended for the purpose of displaying, analyzing, or printing medical information about a patient or other medical information (such as peer-reviewed clinical studies and clinical practice guidelines);
  3. “Intended for the purpose of supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition; and
  4. “Intended for the purpose of enabling such health care professional to independently review the basis for such recommendations that such software presents so that it is not the intent that such health care professional rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient.”

Non-Device software, under the guidance, would be intended for use by a healthcare professional and would allow for independent review of the basis for its recommendations. CDS software intended for caregivers or patients is considered Device CDS along with any software that doesn’t allow for independent review, regardless of the intended user.

The guidance also explains how the FDA will enforce oversight of CDS software deemed to be devices through use of the International Medical Device Regulators Forum (IMDRF) Software as a Medical Device (SaMD) risk categorization framework.

The framework categorizes SaMD risk based on the state of the health condition and the significance of information provided by the SaMD. Device CDS software that is used to inform clinical management for non-serious issues will not need to comply with FDA device requirements unless the intended users are non-healthcare professionals and the software does not allow for independent review.

HRI impact analysis

The American Medical Association (AMA) has been generally supportive of CDS software. The AMA has written that “[CDS software] enables [a clinician] to reduce variations in clinical practice and identify gaps in care to improve patient outcomes.”

But the association also has some reservations. It suggests that developers of CDS software must do their part to ensure that high-quality data are used, that CDS software is not marketed as the end-all solution for users, and that systems are properly maintained to provide consistent high-quality patient care. The association also outlined concerns around patient privacy.

With this new guidance, CDS developers have better clarity on whether they need to go to the FDA and what questions they need to ask while creating CDS software, a luxury that wasn’t available until now. Software can be brought to market faster by conforming it to the criteria established by the FDA. 

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Contact us

Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Alexander Gaffney

Senior Manager, Health Research Institute, PwC US

Tel: +1 (202) 836 1604

Crystal Yednak

Senior Manager, Health Research Institute, PwC US

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