The US Food and Drug Administration (FDA) on Friday released two draft guidances for public comment clarifying its policy for when manufacturers should submit a 510(k) for changes made to a medical device or its software.

According to FDA, the new guidances preserve "the basic format and content of the original, with updates to add clarity," which the agency says will help align industry and agency interpretations of when a device modification warrants further FDA review.

Background

Under federal regulations, device makers are required to submit a 510(k) when a change to a device "could significantly affect the safety or effectiveness of the device," or when there is a "major change or modification in the indented use of the device."

However, despite issuing guidance on the topic in 1997, FDA says that further clarification is necessary in order to align industry and agency interpretations of the requirements.

The new guidances come five years after FDA's controversial first attempt to replace its existing guidance in 2011. However, FDA withdrew the guidance after Congress ordered the agency to rethink its policies in light of strong industry opposition. At the time, industry felt FDA's 2011 draft guidance would increase the number of changes that would require a new 510(k).

Then, in 2013, FDA held a public workshop with industry and patient groups to discuss its approach to 510(k) device modifications and sent a report to Congress on the issue in 2014, which said the agency would leave the 1997 guidance mostly as-is.

"The agency's analysis has shown that although there are certain areas of its 510(k) device modifications policy that should be updated or revised, the 1997 guidance is a solid foundation and should remain mostly unchanged," FDA said in the report.

According to Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren, FDA used the input it received from the workshop to inform the recommendations in the draft guidances.

"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," Shuren said.

In the 73-page guidance, FDA lays out its guiding principles for what can constitute a change requiring a 510(k) device modification. The guidance also includes five flow charts intended to help device makers make a determinations for specific changes.

Software Changes

Consistent with its report to Congress, FDA released a separate guidance detailing when changes to a medical device's software might require a 510(k) device modification.

The guidance includes a flow chart detailing common changes and whether they are likely to require a new 510(k), or whether the device maker should simply document the changes.

Figure 1. When to File a New 510(k) for a Software Change to an Existing Device

Notably, FDA says that updates made to strengthen a device's cybersecurity that do not affect other aspects of the device will typically be considered minor changes and won't require a new 510(k).

Similarly, if a software change is only made to return a device to the specifications of the most recently cleared version of the device, a new 510(k) is most likely unnecessary.

However, FDA says that a 510(k) is likely to be required if a software change has the potential to cause or modify a "hazardous situation," necessitate a new risk control measure or affect the clinical functioning of the device.

Deciding When to Submit a 510(k) for a Change to an Existing Device

Deciding When to Submit a 510(k) for a Software Change to an Existing Device

FDA Press Release