Draft guidance from the Food and Drug Administration is seeking to clarify when medical device manufacturers need the agency’s approval to make changes to their products, potentially replacing guidance that had remained unchanged since 1997.
The standard is whether the “overall structure” of the device will be altered. If so, the draft guidance says a company should consider filing a 510(k) form, demonstrating the device is “substantially equivalent to another marketed device not subject to premarket approval.” Some examples of when re-approval would be needed include updating software to support new hardware, changes to the device’s “core algorithm” and any tweaks that may create a hazardous situation for users.
“These draft recommendations are intended to help manufacturers determine when a change is significant enough to warrant FDA review, including major changes or modifications to the intended use that could significantly impact safety and effectiveness,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “Medical device technology evolves quickly, and not all changes made to marketed devices alter their safety profile or require our review.”
The guidance also covers what changes are unlikely to require a 501(k). Some examples are obvious, such as not needing regulatory approval for changing the company logo on a device or other purely cosmetic changes, but others may save considerable time for manufacturers. Most updates made to strengthen cybersecurity on a device wouldn’t require a 501(k).
“Cybersecurity updates are considered a subset of software changes that are implemented to strengthen the security of a system, protect information, and reduce disruption in service,” the guidance says. “FDA expects manufacturers to ensure that such changes do not impact the performance of the device by performing necessary analysis, verification and/or validation.”
The guidance also says a software update that “only restores the device to the specifications of the most recently cleared device” would likely not require regulatory approval either.
Comments on the guidance will be accepted through Nov. 6.