FDA Keeps Flowcharts in New Draft Guidance on Device Modifications

FDA is keeping its popular flowcharts in a new draft guidance that updates recommendations on when device makers need to submit a new 510(k) after making device modifications. The guidance has been three years in the making after the agency held a public stakeholder meeting in 2013 on revamping future policy on 510(k) modifications. A separate guidance also released is intended to clarify when manufacturers should submit a 510(k) after making modifications to software used with certain 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,” CDRH director Jeffrey Shuren is quoted in a release as saying. “Medical device technology evolves quickly, and not all changes made to marketed devices alter their safety profile or require our review.” When finalized, the documents are intended to provide improved clarity on minor device changes that do not require FDA review, the agency adds.

One of the discussion topics during the 2013 meeting was more reliance on risk management principles when determining whether a modification required a new submission. The draft guidance repeatedly discusses how a device modification that leads to a “significant change in the device’s risk profile likely requires a new 510(k).” It includes a section on “principal factors” to consider in conducting a risk assessment to determine whether a device modification leads to a significant change in the device’s risk profile. Manufacturers are encouraged to use the risk assessment considerations in conjunction with the logic schemes and decision-making flowcharts provided. It also recommends that manufacturers use an accepted method of risk assessment, such as ISO 14971, an FDA-recognized standard that provides a framework for systematically managing risks of medical devices throughout the total product life cycle.

In general, the guidance says, “the assessment of risk in deciding whether to submit a new 510(k) should identify all possible risks, and then focus on risks whose existence and characteristics are supported by objective scientific evidence. It is not necessary to focus on hypothetical risks that are not supported by scientific evidence or those that are determined to be negligible due to both the low probability of occurrence and low severity of harm. The manufacturer should then explore the severity and probability of occurrence of the harm to determine whether the device modification could significantly affect safety or effectiveness and require a new 510(k).”

Additional updates in the draft guidance recommendations include:

• Updated sections and flow charts to provide more clarity to manufacturers on when they likely are 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 ones that likely do not in order to help guide manufacturers during their own decision-making on whether to submit a new premarket notification.