Digital health regulatory framework in the US for Software as a Medical Device (SaMD)
Deloitte has released an analysis report to help the FDA streamline its regulatory process for Software as a Medical Device (SaMD), to ensure safe innovation and patient safety.
The Deloitte Center for Government Insights has recently released an analysis report to help the FDA better establish a regulatory framework for the fast-growing software as a medical device (SaMD) industry. The report takes a close look at the existing and proposed regulations. It makes suggestions on how the FDA can improve features like the pre-certification pilot program, for safer innovation that will benefit patients.
A glance at the Deloitte report
The report defines what software can be considered SaMD, and what is not. It examines the FDA Pre-Cert Pilot Program in which the FDA has been developing risk-based policies. Key players in the SaMD industry include medical tech companies, FDA and other regulators, healthcare providers, patient advocates, life science companies, healthcare providers and academics and researchers.
Based on its analysis of a convening session with these stakeholders, Deloitte has offered suggestions on points such as how much information companies should provide to the FDA in order to be cleared to market their product.
Deloitte also takes a look at the proposed Regulatory Development Kit designed to help companies learn about FDA regulatory processes. It further offers suggestions on how to measure an organization’s commitment to excellence in the pre-certification stage.
A third capability of the regulatory framework suggested is the Multi-Stakeholder Real World Data Capability, which would help software makers communicate data collected by SaMD for safety verification.
Deloitte proposes that a single Integrated Online Collaboration Capability for efficient communication between the various stakeholders involved.
The need for regulation
The FDA doesn’t regulate general wellness applications such as fitness trackers and low-level apps that help patients and caregivers manage health within FDA-approved parameters.
SaMD, on the other hand, needs special regulation to differentiate it from traditional medical devices. According to the International Medical Device Regulators Forum (IMDRF), SaMD is “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” SaMD can diagnose conditions, suggest options for treatment and guide clinical management.
The FDA offers some examples of SaMD. These include software for coronary physiological simulation like CircAdapt and Microlife’s algorithm to detect atrial fibrillation.
Software that is not actively and directly offering a medical service is not considered SaMD. The FDA website states that software that drives motors in a medical device, or maintains a medical device, or relies on data from a medical device but doesn’t have a medical purpose on its own are all examples of non-SaMD software.
According to the FDA, a need for “regulators across the globe recognized the need to converge on a common framework and principles for [SaMD] that enables all stakeholders, including regulators, to promote safe innovation and protect patient safety.”
Deloitte states, “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.”
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