Michael Werner is a Partner for Holland & Knight's Washington, D.C. office.
Jennifer Nowak is an Associate for Holland & Knight's Washington, D.C. office.
On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology. For years, software manufacturers developing products intended for use by health care providers to assist with decision-making in the diagnosis, treatment, or prevention of a disease or condition have been forced to draw from policy and guidance documents addressing other forms of health IT to try to determine how FDA would regulate their CDS technology.
Last December, Congress took action in the 21st Century Cure Act (Cures Act) to clarify regulatory treatment of these technologies. The Cures Act excludes certain types of CDS from the definition of a medical device. However, how FDA would implement the new statutory language remained unclear. FDA's "Draft Guidance on Clinical and Patient Decision Support Software" provides clarification.
In general, when addressing its oversight of health IT products, FDA has placed products in three categories: (1) medical devices assigned a risk classification and actively regulated by FDA, (2) products deemed by the agency to not be medical devices and therefore not regulated by the FDA, and (3) low risk technology that meets the device of a medical device, but over which FDA does not intend to exercise active oversight. Prior to enactment of the Cures Act, industry had to guess into which category its CDS products would fall.
The Cures Act, enacted in December 2016, amended the statutory definition of "medical device" in Section 201(h) of the Food, Drug and Cosmetic Act (FDCA) to explicitly exclude certain types of CDS. Specifically, most software intended for use by a health care professional that meets the following criteria are not medical devices:
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) Is 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) Is 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) Is 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.
In the Draft Guidance, FDA provides an explicit definition for CDS: any product that meets the first three criteria above are CDS. If the CDS function also meets the fourth criterion, the CDS is exempt from the definition of medical device and therefore not regulated as such. As the Cures Act criteria apply only to products intended for use by a health care professional, FDA also created terminology for similar products intended for use by patients or other lay persons – this technology is coined "patient decision support software" or "PDS."
While the criteria that define a product as CDS are clear. the fourth criterion exempting CDS from the definition of a medical device is vague. The Draft Guidance provides useful additional detail to determine whether technology meets the standard for exemption. FDA states that it interprets 360j(o)(1)(E)(iii) (the fourth criterion) to mean software functions that clearly explain and identify:
1) the purpose or intended use of the software function;
2) the intended user (e.g., ultrasound technicians, vascular surgeons);
3) the inputs used to generate the recommendation (e.g., patient age and gender); and
4) the rationale or support for the recommendation.
Thus, the intended user should be able to reach the same recommendation on his or her own without relying primarily on the software function. To that end, FDA further states that the sources underlying or supporting the recommendation provided by a CDS product should be: identified and easily accessible to the user; understandable by the intended user; and publicly available (e.g., clinical practice guidelines, published literature).
A few examples of products the FDA says are not medical devices include:
1) Software that provides recommendations to health care providers by matching patient-specific information (e.g., diagnosis, treatments, allergies, signs or symptoms) to reference information the medical community routinely uses in clinical practice (e.g., practice guidelines) to facilitate assessments of specific patients.
2) Software that provides health care professionals with recommendations on the use of a prescription drug that are consistent with the FDA-required labeling.
3) Software that uses rule-based tools that compare patient-specific signs, symptoms, or results with available practice guidelines (institutions-based or academic/clinical society-based) to recommend condition specific diagnostic tests, investigations or therapy.
FDA indicates that it will focus its regulatory oversight on CDS "and other software functions for health care professionals" it classifies as devices and provides some examples of such devices, which include software that uses a proprietary algorithm to analyze patient information, when the basis of the resulting recommendation is not available to the health care practitioner.
Interestingly, the guidance mentions that there are many types of software not covered under 360j(o)(1)(E) for which it intends to continue exercising enforcement discretion, but only provides one example – software that performs calculations routinely used in clinical practice. FDA indicates that other examples are provided in its guidance on mobile medical applications.
Accordingly, and ironically, the guidance fails to address one of its own stated purposes – that is, to identify the types of decisions support software which may meet the definition of a device but for which FDA does intend to enforce compliance with the FDCA.
Companies with CDS products that are not exempt from the medical device definition should consider submitting comments to the draft guidance to the FDA docket requesting that additional guidance, clarification, and examples on this particular topic be included in the final guidance documents. Comments are due on February 8, 2018.
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