Health IT

FDA has a role to play in software updates to medical devices

Placeholder image for article template

The Food and Drug Administration is seeking comment on a proposed guidance that outlines when software changes to medical devices would require manufacturers to submit a premarket notification.

Before putting medical devices on the open market, manufacturers are required to attest to the FDA that the product is secure and effective. After a device is cleared, however, the need for software updates may arise to bolster cybersecurity, fix bugs or generally improve functionality. If those updates potentially introduce risk to a device's cybersecurity or alter its functionality, FDA wants to know about it before the revised device hits the open market.

But the FDA also recognized that there is a threshold for the level of medication that requires government attention.

"Medical device technology evolves quickly, and not all changes made to marketed devices alter their safety profile or require our review," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health

The guidance includes an infographic flowchart of six questions, as well as a series of example cases, to help manufacturers and FDA staffers determine whether a notification is required.

In instances of routine cybersecurity updates or software restorations, a notification would likely not be required. Common styles of software changes that fall into this category include cosmetic changes or requirement clarifications that do not alter device functionality.

However, more-complex software changes that might create exploitable vulnerabilities would be subject to a new submission.

The criteria that would trigger a new submission include changes that introduce a potentially hazardous situation; modify or create a risk control measure; or affect the functionality or intended use of the device. The FDA draft guidance suggests that  infrastructure and architecture updates, core algorithm modifications or maintenance techniques that entail the re-writing of software could be among the changes that would require a new vendor attestation.

The period for public feedback will remain open until Nov. 7, when FDA will begin to finalize the guidance.

About the Author

Chase Gunter is a former FCW staff writer.

Featured

  • Comment
    Pilot Class. The author and Barbie Flowers are first row third and second from right, respectively.

    How VA is disrupting tech delivery

    A former Digital Service specialist at the Department of Veterans Affairs explains efforts to transition government from a legacy "project" approach to a more user-centered "product" method.

  • Cloud
    cloud migration

    DHS cloud push comes with complications

    A pressing data center closure schedule and an ensuing scramble to move applications means that some Homeland Security components might need more than one hop to get to the cloud.

  • Comment
    Blue Signage and logo of the U.S. Department of Veterans Affairs

    Doing digital differently at VA

    The Department of Veterans Affairs CIO explains why digital transformation is not optional.

Stay Connected

FCW INSIDER

Sign up for our newsletter.

I agree to this site's Privacy Policy.