FDA issues new guidance on when medical device manufacturers should submit a 510(k)

Technology is evolving at a rapid rate, allowing medical device manufacturers to make changes and upgrades that result in improved products. But at what point in the upgrade of an existing device is approval needed from the U.S. Food and Drug Administration?

That’s a question the FDA is looking to answer with the issuance of two draft recommendations designed to clarify its policy for when manufacturers should submit a 510(k) for changes made to a medical device or its software.

A 510(k) is a pre-marketing submission made to the FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to pre-market approval.

Manufacturers are required by law to submit a new 510(k) when changes or modifications made to an existing device could significantly affect its safety or effectiveness or the manufacturer makes a major change or modification in the intended use of the device.

“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 Dr. Jeffrey Shuren, 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.â€

In its 76-page report the FDA lays out guidance for what can constitute a change requiring a 510(k) device modification.

The FDA notes that “a single logic scheme containing all of the necessary steps would be large and cumbersome and could be quite daunting†so one is not included in the guidance. Instead, the guidance uses flowcharts and text to help manufacturers arrive at a decision on whether to submit a new 510(k) for a change to an existing device. Generally speaking, however, changes that could significantly alter a device’s clinical functionality or performance specifications would require a new 510(k).

In addition, the FDA released a separate guidance outlining when changes to a medical device’s software might require a 510(k) device modification. It points to four common types of software changes that could require a 510(k) notification to be filed:

• Infrastructure: The complexity of the change should be taken into consideration while determining whether the change requires a new 510(k).
• Architecture: Changes are modifications to the overall structure of the software.
• Core algorithm: Changes are modifications made to an algorithm that directly drive the
• device’s intended use.
• Re-engineering or re-factoring: Changes that are minor modifications to enhance the maintainability of the device within its specification context are unlikely to require a new 510(k). Changes involving significant software re-write likely require a new 510(k) because of the impact on the performance and on the risk controls.

In January, the FDA issued cybersecurity guidance on medical devices. It details the agency’s recommendations for monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they have entered the market.

The FDA will accept comments and suggestions for 90 days on the newly proposed guidance.

The Health Law Offices of Anthony C. Vitale provides advice regarding medical devices, 510k’s as well as new device applications. If you have any questions or concerns, feel free to contact The Health Law Offices of Anthony C. Vitale at 305-358-4500 or email us at info@vitalehealthlaw.com.