On September 26, 2019, FDA released a suite of revised digital health guidances, which includes the following:

• Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act (“Section 3060 Changes Guidance”) – Final

• Policy for Device Software Functions and Mobile Medical Applications (“MMA Guidance”) – Final

• General Wellness: Policy for Low Risk Devices (“General Wellness Guidance”) – Final

• Off-The-Shelf Software Use in Medical Devices (“OTS Software Guidance”) – Final

• Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (“MDDS Guidance”) – Final

• Clinical Decision Support Software (“CDS Guidance”) – Draft

In addition to the expected changes, FDA also made significant substantive changes to the Clinical Decision Support Software ("CDS") Guidance.  We describe both the general changes to the full suite of digital health documents and the major CDS Guidance changes below.The primary objective of these revisions was to bring the guidances into alignment with the software function exemptions described in Section 3060 of the 21st Century Cures Act (the “Cures Act”). The medical device community has anticipated these changes since Congress passed the Cures Act almost three years ago in December 2016.

General Updates to All Guidances Related to Software Function Exemptions

Section 3060 of the Cures Act exempts from the statutory definition of “device” software functions intended for:

1. Administrative support of a health care facility.

2. Maintaining or encouraging a healthy lifestyle.

3. Use as electronic patient records.

4. Transferring, storing, converting formats, displaying data and results.

5. CDS that meets certain criteria.

The brand-new Section 3060 Changes Guidance summarizes the revisions FDA made to the MMA Guidance, General Wellness Guidance, OTS Software Guidance, and MDDS Guidance relating to the first four of these software function exemptions. It serves as a useful compilation explaining the agency's interpretations of the Cures Act and its reasoning behind each of the revisions. The policy changes made in relation to the fifth exemption, the CDS software function exemption, are covered in the CDS Guidance (described below).

In general, the Section 3060 Changes Guidance describes many straightforward and predictable revisions derived from the legislative exemption of software functions for administrative support, general wellness, electronic patient records, and medical device data transfer, storage, conversion, and display from regulation under the agency’s device authorities. For each software function exemption, FDA explains:

1. That software functions meeting the applicable Cures Act criteria are exempt and are no longer within the scope of the corresponding guidance;

2. That the following product types remain within the scope of the corresponding guidance and are governed by FDA device regulations:

   • Software functions not meeting the applicable Cures Act criteria; and

   • Hardware devices intended for the functions defined in the Cures Act (e.g., hardware devices intended for general wellness that do not depend on software for such functionality); and

3. How the scopes of and the examples described in each of the MMA Guidance, General Wellness Guidance, OTS Software Guidance, and MDDS Guidance were revised to reflect these software function exemptions.

Some Significant Changes to the MMA Guidance

FDA made two important changes to the MMA Guidance that deserve special attention. First, the agency adapted the terminology of the MMA Guidance to be consistent with the Cures Act, which has the effect of expanding the scope of the guidance. In previous versions, the MMA Guidance was restricted by its terms to software applications installed on off-the-shelf mobile computing platforms (e.g., smartphones), and it was unclear how the guidance applied, if at all, to software applications installed on general computing platforms (e.g., desktop computers). However, since the Cures Act exempted certain “software functions” from the definition of “device,” FDA revised the MMA Guidance to clarify that it applies to individual “software functions,” rather than the applications as a whole, and that software functions intended for mobile and general computing platforms are within the scope of the guidance.

Second, FDA made extensive changes to the software function examples described in the MMA Guidance. When the Cures Act was signed into law, multiple functions previously provided as examples of “software functions for which FDA intends to exercise enforcement discretion” became exempt, forcing FDA to move them into the discussions of “software functions that are NOT medical devices.” In addition, FDA revised examples of software functions for active patient monitoring or analyzing patient-specific data described in the section on “software functions that are the focus of FDA’s regulatory oversight” to reflect the exemption of software functions intended for the transfer, storage, conversion, and display of medical device data. It is worth noting that while the Cures Act caused FDA to place a number of software function examples in the non-device category, it did not substantially alter the descriptions or examples of software functions that are subject to active FDA oversight under its device authorities.

Substantial Changes to the CDS Guidance

Of all the revised digital health guidances, FDA made the most substantive revisions to the CDS Guidance. First, FDA clarified its interpretation of the four Cures Act criteria (which are provided in full on pages 6-7 of the CDS Guidance) that a software function must meet in order to be considered non-device CDS. Second, the agency eliminated the separate designation of “Patient Decision Support Software,” thereby unifying CDS software functions intended for both health care professionals (“HCPs”) and patients/caregivers under the same umbrella. It also clearly stated that no CDS intended for patients/caregivers will be exempt from FDA oversight because such software functions cannot meet the third and fourth Cures Act criteria, which require that the CDS be intended for use by HCPs only. Third, as a helpful addition for product developers, the revised guidance includes more detailed examples of software functions in the following four categories:

• Examples of Non-­Device CDS Functions

• Examples of Device CDS for which, based on FDA’s current understanding of the risks of these devices, FDA does not intend at this time to enforce compliance with applicable device requirements

• Device CDS on which FDA intends to focus its regulatory oversight

• Examples of device software functions that are not CDS on which FDA intends to focus its regulatory oversight

Finally, and by far the biggest change with respect to the revised draft CDS Guidance, is that FDA applied the International Medical Device Regulators Forum ("IMDRF") software as a medical device (“SaMD”) risk categorization framework to determine whether device CDS should fall within the focus of regulatory oversight or under enforcement discretion. The previous version of the guidance did not include this risk framework, which only applies to device CDS software functions. In the IMDRF framework, the risk level associated with each software function is based on two overarching factors: (1) "the significance of the information provided by a SaMD to a health care decision: to treat or diagnose, to drive clinical management, or to inform clinical management”; and (2) “the state of the patient’s health care situation or condition: critical, serious, or non-serious.” Based on the revised CDS Guidance, the agency believes that directly treating/diagnosing patients or driving clinical management is outside the scope of CDS, and therefore, all CDS software functions must be for the purpose of informing clinical management, the lowest risk level in the first IMDRF factor.

Accordingly, because all CDS are the same with respect to the first factor, the second factor largely determines where a specific CDS software function falls in the risk framework. Under FDA’s applied framework, only two types of device CDS are under enforcement discretion – meaning the agency will not seek to regulate them although technically it has the authority to do so (relevant factors are underlined): (1) CDS intended for use by HCPs to inform clinical management of non-serious conditions, and (2) CDS intended for use by a patient/caregiver to inform clinical management of non-serious conditions as long as it allows the user to independently review the basis for the CDS recommendations. All other types of device CDS are subject to FDA’s medical device oversight.

It is noteworthy that FDA’s determination of risk for SaMD products appears to be inconsistent with the general IMDRF framework. Although FDA essentially assigns CDS for non-serious and serious conditions to different risk levels, the IMDRF framework assigns software functions intended to inform clinical management of non-serious and serious conditions to the lowest risk level. When mapping the IMDRF framework to FDA’s factors for risk assessment of CDS software functions, one would assume that FDA would exercise enforcement discretion for two additional categories of device CDS based on the risk levels: CDS intended for use by HCPs to inform clinical management of serious conditions, and CDS intended for use by a patient/caregiver to inform clinical management of serious conditions that allows the user to independently review the basis for the CDS recommendations. FDA does not explain this departure from the IMDRF framework, and we expect this to be a focus of discussion during the comment period for the revised draft CDS Guidance, which is open until December 26, 2019. We encourage all interested stakeholders to provide feedback to the agency so it can be considered during the development of a final guidance document.