In the latest update on a years-long process, FDA has offered more commentary on what its new 510(k) device modifications draft guidance is likely to include. Speaking this week at the Regulatory Affairs Professionals Society (RAPS) 2015 Regulatory Convergence in Baltimore, an FDA official discussed a number of issues that are top of mind for the agency: more device-specific guidances, clarification of key terms, details on the impact of materials changes, and documentation recommendations.
FDA's current 510(k) modifications policy is based on a 1997 guidance document, "Deciding When to Submit a 510(k) for a Change to an Existing Device." A 2011 draft guidance to revise the 510(k) modifications policy was ultimately withdrawn after industry concerns that the changes proposed would significantly increase the number of 510(k) submissions required. As part of the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, FDA was required to send a report to Congress on its 510(k) modifications policy. The Report to Congress followed in 2014, detailing the agency's thoughts on the next draft guidance.
This week, Michael Ryan, regulatory advisor in CDRH's Office of Device Evaluation, echoed that report, saying that the forthcoming draft guidance would not include "paradigm shifts" but would make "targeted improvements." Ryan declined to give an exact timeline for publication, though the draft guidance is anticipated sometime next year.
FDA is looking to clarify key terms like "could significantly affect" and a "major" change in intended use, Ryan said. Other planned clarifications include specific part of the 1997 guidance, including the need for submissions with changes in labeling and materials. Ryan pointed out that the 1997 guidance required a 510(k) submission for any changes to those implant materials that come in contact with body tissue or fluids. "That's not always necessarily true," he said.
The agency plans to add more device-specific guidance with modification information. Ryan pointed to current examples of device types with this kind of guidance—pulse oximeters and contact lenses—and noted that "these would supersede the general guidance document, supplement it, and put out additional information for manufacturers of those types of devices."
One popular feature of the 1997 guidance is the flowcharts, which allows manufacturers to follow the visual charts through basic questions to support a decision of whether a 510(k) submission is needed or not. Ryan acknowledged the usefulness of this feature, but emphasized that the next draft guidance will have flowcharts that more closely align with the draft guidance text. "We all love flowcharts, myself included, but as great a tool as they are, they can sometimes be misleading . . . we want to try to make sure the text is emphasized and that it matches the flowchart wherever possible," he said.
Other key issues FDA plans to tackle in the next draft guidance are:
- Design verification and validation activities and their impact on modifications decisions.
- Comparisons should be made between the modified device and the original device, not a predicate. FDA is looking for the signficance of that change, not substantial equivalence, Ryan pointed out.
- Manufacturers should consider all risks and use risk assessments. "That's probably the most important piece that you can do to make sure you come out with the correct decision, is make sure you're assessing all the risks appropriately," Ryan said.
- Materials changes. Ryan described this as "one of the most difficult issues we have in deciding whether a 510(k) is necessary," since changes in materials can impact biocompatibility and device performance. Ryan added that the new draft guidance will also address how changes in suppliers and vendors can impact 510(k) decisions.
- Good documentation is important and the next draft guidance will give manufacturers more recommendations on how to craft good documentation.
Ryan emphasized that the draft guidance will be open to public comment and any finalized guidance will take into account any input from commenters.
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