At the end of July, FDA released a tangible plan for promoting innovation in the development of digital health products. In this Digital Health Innovation Action Plan, FDA acknowledges that digital health technologies are critically important in advancing health care, and that traditional FDA pathways to market are not well suited for all of these technologies. Over the last few years, FDA has taken a deregulatory approach with respect to low risk digital health products and has issued guidance regarding its enforcement discretion approach to wellness products, medical device data systems, medical imaging communication and storage devices and certain mobile apps. However, there still has been uncertainty with respect to whether, and how, other digital health technologies will be regulated. This new plan paves the way for additional regulatory clarity and streamlined pathways to market for digital health developers.
Some of the key aspects of the plan include:
- Issuing 21st Century Cures Act implementation guidance. The Cures Act, which was passed in December of last year, includes provisions clarifying FDA’s regulation of software. Specifically, these provisions explicitly exclude certain software from FDA’s definition of a “medical device,” including electronic health records and software that encourages healthy living, displays, transmits, stores or performs limited conversion of medical device data and supports administrative activities. As a result, these products are not subject to FDA’s oversight. The planned draft guidance, which the Agency hopes to release by the end of the year, will reconcile these new Cures provisions with existing FDA guidance. Cleaning up and clarifying policies in this space will help solidify FDA’s interpretations and reduce regulatory uncertainty. FDA also commits to providing guidance regarding products that include regulated and unregulated functionality. The Cures Act makes clear that the fact that an unregulated application co-exists with a regulated application within a solution does not submit the unregulated functionality to FDA oversight. FDA still may consider how the unregulated software impacts the safety and effectiveness of the regulated software, but the unregulated software nevertheless remains unregulated.
- Running a pilot program focused on “pre-certification” of digital health developers. In September, FDA will launch a pilot pre-certification program applicable to manufacturers of stand alone medical device software. The purpose of the program is to develop objective criteria that, if met, would demonstrate an entity’s ability to reliably develop high quality, safe and effective software. The intent is for FDA to use these criteria to develop a framework to pre-certify software developers that satisfy the requirements. In turn, pre-certified developers would be subject to a streamlined premarket review for new lower-risk products (e.g., less premarket submission information would be required and/or review times would be faster). FDA indicated that, in some instances, pre-certified companies would be able to market certain lower risk products, that presumably would be subject to 510(k) clearance today, without any premarket review at all. However, to account for reducing the front end requirements, FDA envisions that developers will collect real-world data once their products hit the market to assure they are safe and effective.
- Issuing CDS software guidance. By the first quarter of 2018, FDA plans to issue draft guidance detailing which CDS is not subject to FDA regulation. The Cures Act carves out transparent, professional use CDS from the definition of a medical device. This carved-out CDS is software that is not intended to be relied upon as the primary basis for a clinical decision, but rather allows the healthcare professional to independently review and assess the underlying rationale for the software recommendation in connection with making a clinical decision. While guidance on how FDA interprets the relevant Cures language on this issue will be helpful, it is equally, if not more important, for the Agency to provide guidance on CDS that falls outside of the Cures Act exemption (e.g., consumer clinical decision support, machine learning and non-transparent CDS).
- Finalizing 510(k) Guidance on Software Changes. FDA’s Digital Health Innovation Action Plan also includes finalizing the draft guidance on “Deciding When to Submit a 510(k) for a Software Change to an Existing Device.” This guidance is the software counterpart to FDA’s draft guidance on “Deciding When to Submit a 510(k) for a Change to an Existing Device,” which has had a controversial past. FDA first attempted to revise its guidance on when a 510(k) is required due to a change made to a device in 2011. FDA was required by Congress to withdraw its 2011 draft guidance due to the potentially significant impact the draft guidance would have on industry. In August 2016, FDA published this pair of draft guidance documents. Given the disagreement and debate that has surrounded this topic, a definitive FDA approach will provide manufacturers greater certainty regarding any submission requirements for the range of software changes made to traditional medical devices, as well as to stand alone software devices.
- Adopting the IMDRF’s Approach to Clinically Evaluating SaMD Once Finalized. FDA also intends to adopt the final version of the Software as a Medical Device (SaMD): Clinical Evaluation guidance as published by International Medical Device Regulators Forum (IMDRF). FDA released draft guidance that incorporated this IMDRF document in 2016. While it is unclear how procedurally FDA will adopt a final version of the IMDRF policy without public review and comment, the IMDRF framework will nevertheless provide insight into FDA’s thinking on clinical evaluation requirements for medical device software given the Agency’s leadership in the IMDRF work group that drafted the document and this pre-emptive endorsement. It also serves as a reminder that despite FDA efforts to minimize regulatory burdens for low risk digital health products, moderate and high risk medical device software remains subject to FDA’s premarket review. The 21st Century Cures and CDS guidance, both of which are expected after IMDRF’s SaMD’s Clinical Evaluation document is finalized, will be instrumental in clarifying which digital health products are subject to such requirements.
Although FDA has been expected to release many of these policies for years, the Digital Health Innovation Action Plan is aggressive, promising five draft or final guidance documents in just over six months, while at the same time conducting the pre-certification pilot program. Whether this is a reflection of the new administration, a new Commissioner or a new (or renewed) focus on digital health innovation, it is a welcome development and one that will be watched closely by software companies, traditional medical device manufacturers and patients alike.