FDA Releases Draft Guidance Documents Clarifying When To Submit A 510(k) For Device, Software Modifications

By Jof Enriquez,
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The U.S. Food and Drug Administration (FDA) has issued updated draft guidance for manufacturers deciding whether to submit a 510(k) application when making modifications to medical devices already in the market. Related, it also released complementary draft guidance on software modifications.

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA).

FDA issued the original guidance on the topic in 1997. After recommending an updated document in 2011, FDA withdrew it after Congress ordered the agency to rethink its policies in light of strong industry opposition, according to RAPS. In 2013, the agency held a public workshop to discuss proposed changes with industry stakeholders. FDA later reported to Congress that it intends to retain the original guidance mostly intact.

The updated guidance indeed retains the basic format and content of the original guidance issued by FDA in 1997, but with updates for clarity. FDA's Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren wrote in a news release that industry stakeholders and patient advocates helped FDA incorporate changes to the guidance in order to "strike the right balance between safety and effectiveness of modified devices and advancing device innovation." FDA also drew from existing policy and related guidance in updating the draft guidance document, including:

• Guiding principles, including recommendations for manufacturers to conduct a risk-based assessment in order to determine whether a modification could significantly affect the safety or effectiveness of the device.
• Updated sections and flow charts, which clarify provide for manufacturers when they are likely required to submit a new 510(k) for labeling, materials, technology, engineering, and performance changes.
• Examples of specific device changes that likely require a new 510(k), and changes that likely do not, in order to help guide manufacturers during decision-making on whether to submit a new premarket notification.

FDA recommends that manufacturers use the guidance’s flowcharts in concert with the guiding principles. The five flowcharts and corresponding text are intended to guide manufacturers through specific logic schemes, resulting in a clearer decision on whether to submit a new 510(k) for a change to an existing device. There is a flowchart for each main type of change — labeling, technology, engineering, performance, and material changes — as well as for technology, engineering, performance, and materials changes affecting in vitro diagnostic devices.

“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,” wrote Shuren. “Medical device technology evolves quickly, and not all changes made to marketed devices alter their safety profile or require our review.”

Also issued by FDA as a complement to the general 510(k) modifications draft guidance is a draft guidance specific to medical device software modifications. FDA provides a flowchart to direct manufacturers deciding when to file a new 510(k) for a software change to an existing device.

FDA states that, generally, if a change is made solely to strengthen cybersecurity and does not have any other impact on the device, then a 510(k) submission is unlikely. A change to the software that only restores the device to the specifications of the most recently cleared device likewise would not warrant a 510(k). However, any change that would introduce or modify an existing cause of a hazardous situation that would likely result in significant harm, or any change that could significantly alter clinical functionality or performance related to intended use, likely would require a new 510(k).