Deciding When Device Modifications Trigger Submission of New 510(k)

On June 13, 2013, the Food and Drug Administration (FDA) held a 510(k) workshop at the agency’s Silver Spring, MD, headquarters to review revisions to 1997 medical device guidance on when to submit a new 510(k) for a change to an existing device. The FDA held the workshop to comply with provisions of the Food and Drug Administration Safety Improvement Act (FDASIA) that directs it to report to Congress by January 9, 2014, on the structure of new guidance relative to 510(k) changes. The program’s scope included considerations of whether quality systems referenced in FDASIA, or similar regulatory controls, afford reasonable assurance of the safety and efficacy of modified devices.

The program, attended by Arent Fox professional staff, followed a notice in May requesting comment on whether a set of quality system elements could be leveraged by industry to help provide appropriate assurances. The quality system criteria comprised risk management, design controls, critical specifications, risk-based stratification, and periodic reporting.

The FDA will consider stakeholder input from the workshop and comments submitted by July 13, 2013, in determining the design and content of the 510(k) change guidance for existing devices. First, however, the FDA must submit a report to Congress by the end of 2013 outlining the Agency’s planned approach to crafting the guidance. The FDA will finalize guidance in 2014.

What Clients Need to Know  

Industry seems, understandably, to prefer the FDA’s 1997 guidance over the prospect of new regulations that could compromise decision-making relative to the 1997 guidance, now considered industry standard for device changes. Industry stakeholders also are concerned about FDA inspectors reviewing design controls, risk assessments, and other quality system tools covering device modifications, and then “second-guessing” a company’s decision not to submit a new 510(k). In addition, the FDA has not clearly stated whether 510(k) change guidance would be retroactive to previous decisions made utilizing the old guidance. It would seem likely, however, that decisions made under the old guidance will remain in place unless a safety issue arises. Further, industry would like the FDA to craft a clear regulatory definition for the term “significant change” to help limit the scope of device changes that would trigger a new 510(k). Meanwhile, consumer advocates, who orchestrated a significant presence during the workshop, had little to say about the ultimate design of the guidance, instead expressing concern that FDA oversight of 510(k) devices was already insufficient and that any changes to the guidance should result in an increase in FDA oversight.

The FDA appears to be struggling to strike a balance between the device industry and consumer advocates in drafting new 510(k) change guidelines. Even as the FDA posed the issue of companies using quality system controls to assess device changes, such assessments may be problematic because the FDA does not conduct premarket inspections of devices that have been modified. As a result, the Agency would only become aware of these assessments after the fact. Agency inspectors currently do not focus much attention on design controls during inspections, and would need to alter their practices if use of quality system components became an important part of assessing device changes.

Given the opposing points of view, it is difficult to predict the path forward for the FDA on this issue. Arent Fox believes that the FDA likely will draft hybrid guidance that requires device change validation via quality system verification and validation steps, while also providing decision-making criteria that can be used to confirm quality system findings. Such guidance would likely be easier for device companies with sophisticated quality systems to utilize, but will be less user friendly for smaller device companies with more limited quality system knowledge and resources for conducting change determinations.

Stakeholders have until July 13, 2013, to submit comments to docket established for the 510(k) guidance. After reviewing comments, the FDA must then report to Congress by January 9, 2014, on how the new 510(k) guidance should be structured.