FDA Regulation of Mobile Medical Apps

The latest communication from FDA regarding regulation of medical apps notes that mobile medical apps can greatly help patients be proactive and vigilant about their own healthcare. There has been increased demand for medical apps, and many of the apps depend on high levels of feedback between patients and clinicians. The FDA wants to regulate the apps efficiently, in a way that is tailored towards the risks and benefits of the apps.

If an app is intended to treat, diagnose, cure, mitigate, or prevent disease or other conditions, it will likely be considered a medical device subject to FDA regulation. Traditional hardware-based devices undergo change more slowly – and the traditional regulatory framework assessed moderate- and high-risk devices via a lengthy premarket review process. Software as a medical device (SaMD), on the other hand, is unique and constantly evolving.

The FDA responded to SaMD in 2011 with “Guidances with Digital Health Content” and some deregulation. The FDA has continued to oversee SaMD (including mobile medical apps), and recently the International Medical Device Regulators Forum (IMDRF) have established a framework for efficient SaMD review that meets patient and developers’ needs. In 2017, the FDA guidance document, Digital Health Innovation Action Plan, described the agency’s plan for a new regulatory model for digital health technologies consistent with the IMDRF policies – including the precertification program for developers to be assessed for quality in order to qualify for streamlined or no premarket review.

An SaMD manufacturer who is certified to have high quality software design, testing, and other internal quality processes, will truly benefit from the pre-certification program. Low-risk products may not undergo premarket review, and high-risk products would be efficiently reviewed. Plus, post-market data collection on the safety and effectiveness of the device would be streamlined, which ultimately benefits the consumers who demand quality mobile medical apps.

FDA Regulation of Mobile Medical Apps by Jeffrey Shuren, MD, JD; Bakul Patel, MS, MBA; Scott Gottlieb, MD

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