Deloitte report offers guidance for FDA's upcoming software regulation pathway

By Dave Muoio

A recently released analysis report from the Deloitte Center for Government Insights that examines the US’s current and proposed software as a medical device (SaMD) regulatory landscape, and includes suggestions on how the FDA’s pre-certification pilot program and other initiatives could better serve this fast-moving industry.

“The exponential advancement of digital health technologies presents a clear imperative for a new regulatory framework that addresses the key differences between these products and traditional medical devices,” the report’s authors wrote. “Developing a process for effective SaMD regulation could be the first step to creating a new regulatory paradigm for the entire digital health space, and for other regulated industries in which software has become prevalent and disruptive.”

To investigate this space, the consulting group hosted a convening session in February that included representatives from the FDA, medical technology companies, patient advocacy groups, providers, and other major stakeholders. Their goal was to develop a potential framework for SaMD that would clarify the regulatory process, create a risk-based process of data collection for pre-market approvals, and devise a secure means for the agency to access and analyze real-word data collected by the software.

With this in mind, the authors settled on a framework that relies on three core capabilities. The first, a Regulatory Development Kit (RDK), would guide SaMD makers through the regulatory process step by step. The second capability would be FDA’s Pre-Cert program, which the authors note would take an organization’s current standing and risk associated with a specific SaMD into account when granting expedited approval. The third piece outlined by the authors, the Multi-Stakeholder Real World Data Capability, involves a secure means through which software makers could communicate data collected by SaMD post-release verifying safety and suggesting opportunities for meaningful iteration.

Ideally, the authors envisioned each of these capabilities existing within a single Integrated Online Collaboration Capability that would allow SaMD makers to securely and easily submit applications.

“The FDA, in turn, could use [the Integrated Online Collaboration Capability] to conduct the regulatory review, notify organizations of their application status, and share regulatory decisions,” the authors wrote. “The capability could be accessible to all SaMD ecosystem stakeholders. … For example, a SaMD developer alone would have access to its Pre-Cert application and be able to track its SaMD application on its path to market, while all users could have access to data on which SaMDs have been approved, and whether there have been adverse patient events.”

The authors gave the FDA credit for its recent progress in addressing software regulation, which alongside the Pre-Cert pilot includes the December release of three software-focused guidance documents. While the agency hopes to have a new regulatory process for SaMD ready and in place by the end of this year, the report’s authors noted that achieving these goals will require input from the larger SaMD industry.

With the three capabilities of their proposed regulatory framework in mind, the authors concluded their report by outlining a number of areas in which SaMD leaders can lend their expertise. These include the development of a draft SaMD RDK; reaching a consensus and developing methodologies regarding key performance indicators for the Pre-Cert program; devising a business model in which SaMD makers are incentivized to obtain real-world data, share it with the FDA, and implement these data for software improvements; building a prototype for the collaborating online tool described by the authors; and other suggestions.

“As SaMD technology becomes cheaper, more accessible, and more sophisticated, it is likely to play an increasingly important role in healthcare delivery, personalized medicine, and medical research,” the authors wrote. “In this paper, we have outlined one potential framework for the overall regulatory transformation of digital health, but a great deal of work lies ahead.”