On July 27, FDA published its Digital Health Innovation Action Plan. The plan provides details and timelines for the agency’s Digital Health Innovation Plan, announced by FDA Commissioner Scott Gottlieb last month.

The action plan describes the agency’s “next steps” over the coming year to “encourage digital health innovation by redesigning [FDA’s] policies and processes and modernizing [the agency’s] tools so that they match the needs of digital health technology, and provid[e] clarity on those policies and processes so that manufacturers and developers know what they need to do.” The action plan includes three action items: (1) issuing new guidance regarding the regulation of digital health, (2) developing new regulatory approaches to oversight of digital health, and (3) building expertise on digital health within the agency.

Issuing New Guidance

The Digital Health Innovation Action Plan presents FDA’s intent to issue new guidance implementing the 21st Century Cures Act and to expand on the agency’s prior guidance regarding digital health. FDA plans to issue the following guidance documents:

1. 21st Century Cures Act Implementation: FDA intends to issue new draft guidance that would explain the effect of the software provisions of the 21st Century Cures Act on existing FDA policy. The new draft guidance would interpret how Cures affects:

• Mobile Medical Applications. The new guidance would update FDA’s February 2015, final guidance on Mobile Medical Applications.
• Medical Device Data Systems (MDDS), Medical Image Storage Devices, and Medical Image Communications Devices. The new guidance is expected to harmonize FDA’s February 2015 final guidance, announcing an enforcement discretion policy for these devices, and section 3060 of the 21st Century Cures Act, exempting many of the same software products from the definition of a device. Hopefully, the new guidance will address discrepancies between existing guidance and the 21st Century Cures Act (the new statutory provisions, of course, now govern). For example, the existing guidance states that FDA exercises enforcement discretion for MDDS that are not intended to be used in connection with active patient monitoring, whereas the statutory provision includes no similar explicit limitation.
• Low-Risk General Wellness Products. Under FDA’s July 2016, final guidance, General Wellness: Policy for Low Risk Devices, FDA exercises enforcement discretion for general wellness products (both software and non-software products). The 21st Century Cures Act exempts from the definition of a device software functions intended to maintain or encourage a healthy lifestyle that are unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition. The new guidance is expected to address whether FDA will read the 21st Century Cures Act provision to be broader or narrower than the scope of FDA’s enforcement discretion for general wellness devices.
• Laboratory Workflow. The 21st Century Cures Act exempted from the definition of a device a software function intended for administrative support of a health care facility, including laboratory workflow, which the new guidance will address.

1.  
2.  
3. Clinical Decision Support Software: The 21st Century Cures Act exempted from the definition of a device, software functions intended to support or provide recommendations to a healthcare professional, so long as the software enables the healthcare professional to independent review the recommendation and the software is not intended to “acquire, process, or analyze a medical image or a signal from an intro diagnostic device or a pattern or signal from a signal acquisition system.” FDA has not addressed such clinical decision support software in prior guidance, and the meaning of many key terms in this provision will benefit from FDA guidance, including what it means for a health care professional to “independently review” the basis for clinical decision support recommendations. FDA intends to issue a much-needed new draft guidance for public comment during Q1 2018 describing the scope of this provision.
4. Multifunctionality: FDA intends to issue draft guidance by Q1 2018 on how FDA will address products with multiple software functions (a pivotal statutory term in section 3060 of the 21st Century Cures Act). The 21st Century Cures Act exempted from the device definition specific health software functions, but FDA still may assess the “impact” of a non-device function(s) on a regulated device function(s). Many digital health solutions, of course, will include a function(s) that meets the device definition and a function(s) that does not meet the device definition. The new FDA guidance presumably will address not only how FDA will undertake the “impact” assessment of a non-device function(s) on a regulated device function(s), but also provide additional insights on how developers should subdivide digital health solutions into specific “functions” for the purpose of charting a regulatory path forward on particular functions.
5. Deciding When to Submit a 510(k) for a Software Change to an Existing Device: In August 2016, FDA released a draft guidance intended to help manufacturers determine whether a modification requires premarket submission and clearance of a new 510(k). FDA intends to issue the final guidance before the end of 2017.
6. International Medical Device Regulators Forum approach to clinically evaluating software as a medical device (SaMD): In October 2016, FDA issued as draft guidance the IMDRF proposed document on the clinical evaluation of SaMD. FDA intends to issue final guidance once the IMDRF votes on the final document in September 2017.

Reimagining Digital Health Oversight

FDA intends to develop a precertification (“Pre-Cert”) program, under which CDRH could pre-certify “eligible digital health developers who demonstrate a culture of quality and organizational excellence based on objective criteria.” Pre-certified developers could qualify to be able to market their lower-risk devices without additional FDA review or with a more streamlined premarket review.

As an initial step, the agency is launching a Pre-Cert Pilot Program for nine participating companies to help the agency assess the appropriate criteria and structure for the Pre-Cert Program.

For more details on the Pre-Cert Program and pilot program, see our blog post.

Building Agency Expertise

FDA plans to grow the agency’s digital health expertise by hiring new staff for the Digital Health Program within CDRH. FDA will launch an Entrepreneurs in Residence program this fall to allow the agency to obtain input from those with experience in software development.

Elizabeth Guo contributed to this article.