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

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 The FDA draft guidance suggests that  infrastructure and architecture updates, core algorithm modifications or maintenance techniques that entail the re-writing of software could be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.