The FDA regulates software in medical devices and software that is considered a medical device through distinct regulatory pathways, each tailored to ensure patient safety and efficacy while promoting innovation in the rapidly evolving field of medical technology.
Software in a Medical Device (SiMD)
When software is part of a medical device but is not the primary function of the device, it is considered “software in a medical device.” This includes software used for device control, monitoring, data analysis, and other supporting functions.
Regulatory Approach
FDA regulates software in a medical device as part of the overall device, applying the same regulatory requirements as for the device itself.
Manufacturers must demonstrate compliance with relevant quality system regulations, including design controls, risk management, and post-market surveillance.
Depending on the risk classification of the device, premarket submission requirements may include 510(k) clearance or premarket approval (PMA) applications.
FDA guidance documents provide additional clarity on regulatory expectations for software in medical devices, including specific considerations for cybersecurity and interoperability.
Software that is a Medical Device (SaMD)
Software that meets the definition of a medical device and is intended for medical purposes is considered a “software as a medical device” (SaMD). This includes software intended for diagnosis, prevention, monitoring, treatment, or alleviation of disease.
Regulatory Approach
SaMD is regulated as a standalone medical device, irrespective of the platform or delivery mechanism (e.g., mobile apps, cloud-based platforms).
FDA applies risk-based regulatory oversight to SaMD, considering factors such as the intended use, clinical impact, and novelty of the software.
Manufacturers must demonstrate conformity to quality management system requirements and provide evidence of safety, effectiveness, and performance through clinical evaluation and validation studies.
Premarket Submissions
Depending on risk classification, premarket submissions for SaMD may include 510(k) clearance, De Novo classification, or premarket notification (PMA) applications.
Digital Health Software Precertification
FDA’s Digital Health Software Precertification (Pre-Cert) Program offers an innovative approach to streamline regulatory review for SaMD, focusing on the manufacturer’s organizational excellence and product performance.
Summary
The FDA employs distinct regulatory approaches for software in medical devices and software that is considered a medical device. By tailoring regulatory requirements to the specific nature and risk profile of software-based medical technologies, the FDA aims to facilitate patient access to safe and effective innovations while upholding rigorous standards for product quality and performance.
