Regulators are taking strides to focus their attentions on the digital health landscape, as we’ve recently seen from the FCC, Congress, state watchdogs, and now the FDA. Based on recent statements by the newly-appointed FDA Commissioner and the latest user fee programs recently authorized through Congress, the agency intends to invest heavily in the future success of digital health devices. In addition to FDA’s Program Alignment Initiative, this is already the second major medical product paradigm shift announced by newly-minted FDA Commissioner Scott Gottlieb. Given the recent statements by FDA, readers should expect advancements in the digital health realm to include deregulatory policies with a post-market focus, a marketing pathway pilot that assesses manufacturer competencies over product profile, and organizational changes that improve how digital health devices are reviewed by FDA.
In a June 15, 2017 FDA blog, the FDA Commissioner announced an upcoming digital health guidance that will serve to implement the 21st Century Cures Act which explicitly excludes certain functionalities from FDA oversight although they would otherwise meet the definition of a medical device. The Commissioner also stated the guidance would ease the pre-market regulatory burden on additional digital health device categories, provided they are low enough risk. The blog post emphasized a larger role for post-market data, the value it can provide to the total product lifecycle, and its impact on the extent of regulation a manufacturer faces. Specifically, Gottlieb stated that the National Health Evaluation System for Health Technology (NEST) had the potential to accelerate market entry. Two critical requirements for NEST’s success are the ability for medical devices to capture consumer data and a means to communicate that information to the NEST data warehouse. By their very nature, these are two strengths of digital health devices, consequently making these devices suitable for enriching FDA’s parallel real-world evidence initiative. Before full implementation of a system that relies on NEST to reduce the pre-market regulatory burden of certain digital health devices, this concept will probably be explored further in the pilot program mentioned in the same FDA blog post.
The pilot pre-check program concept previously discussed by FDA is similar to TSA airport security. Companies could be provided an expedited pathway to market new or modified digital health products if the company demonstrates in advance that it operates a business continuously focused on quality, demonstrated, for example, by commitments to robust software design, validation, and maintenance. This concept may seem like a radical fast-pass for certain entities, but it is in fact consistent with FDA’s risk-based approach to regulation. The agency has previously used this doctrine to regulate devices, and now, through the new lens of digital health, it would re-focus on the degree of risk presented by specific entities. Ultimately the FDA foresees utilizing third parties to verify that a company satisfies a minimum threshold of quality before permitting the company’s lower risk device to market, whereupon it may be expected to participate in NEST.
Beyond looking forward to more progressive digital health policies, readers should also anticipate a new organizational group dedicated to digital health devices. The digital health unit (DHU) will be an upgrade for how the FDA currently reviews digital health devices. Instead of a physical scientist (who typically reviews conventional mechanical devices) leading the review process, an individual or team with a digital health background will evaluate the device, consulting with physical science specialists on benefits, risks and mitigation measures as they relate to the organ system(s) involved. For instance, instead of the review of a mobile app intended to help diagnose irregular heartbeats being led by the cardiovascular division, who may bring in experts on wireless technology or machine learning, a member of the DHU will be the primary reviewer that consults with cardiovascular specialists on scientific questions as needed. Previously, the FDA had attempted to fit digital health devices into a regulatory framework and culture designed to evaluate conventional, tangible medical devices that are constructed and largely operate mechanically. Now in this rapidly-advancing diaspora, there is firm acknowledgement from FDA leadership that medical device software holds promises of significantly improving consumer health, necessitates its own considerations, and will be a top priority going forward. In recent months, the agency has vowed to put forth practical policies and human capital to help propel the burgeoning digital health enterprise forward. FDA’s Digital Health Innovation Plan is particularly critical considering the short development life cycles and rate at which digital health products are modified and improved. It’s unlikely FDA would initiate a digital health “pre-check” pilot program prior to the DHU materializing and leading the review of submissions. Depending on the stage of development of a digital health product, companies should consider when the appropriate time to engage FDA would be, particularly since applications already under agency review when the DHU is instituted will likely be grandfathered and not eligible for review through the DHU.
In addition, FDA will be seeking public input in order to implement many of the agency’s future digital health policies. Readers should take time to strategically consider their business’ policy goals and how the forthcoming FDA proposals can be molded to advance them.