Software Systems: Medical Device or Not?

by | Apr 23, 2021 | AI, Cloud, Digital Health, Medical Devices, Software

The 21st Century Cures Act (Cures Act) amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) on December 13, 2016, removing certain software systems from the definition of a device under section 201(h) of the FD&C Act.1

The software systems that have been excluded from the definition of a device and subsequently from regulations that would apply to a medical device are:1

  • Software systems used for administrative services within a healthcare facility such as billing, claim processes, managing appointment schedules, business analytics, etc.
  • Software used for maintaining or encouraging a healthy lifestyle and which is not intended to cure, diagnose, mitigate, prevent or treat a disease or medical condition.
  • Software that is used to store electronic records of the patient which includes patient-provided information.
  • Software systems that are used for transferring, storing, converting file formats, or displaying clinical laboratory test data or findings for a health care practitioner, as long as the software is not intended to interpret or analyze test lab or other test results.

This amendment that excludes the above-mentioned software systems from being a device has caused the following guidance documents to be modified to reflect this change:1

  • General Wellness: Policy for Low-Risk Devices
  • Mobile Medical Applications
  • Off-The-Shelf Software Use in Medical Devices
  • Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.

And the following guidance document was obsoleted since it is no longer required:1

  • Guidance for the Submission of Premarket Notifications for Medical Image Management Devices

I am sure that this change comes as a relief for most software developers since they now do not have to comply with the FDA requirements of a medical device. If you have more questions or need more information on how this change may impact your product, call us today at 248-987-4497 or email us at info@emmainternational.com


1FDA (2019) Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act retrieved on 04/18/2021 from https://www.fda.gov/media/109622/download

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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