JAMA Article by FDA Staff – Summary

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.

It seems the key to remaining current with the rapid changes of medical apps is taking a risk-based approach. 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. For the full article click here.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

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