Medical Device- FDA & 510(k) notifications Know When to Submit a 510(k) Notice for a Medical Device Change

The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Examples of device changes and recommendations for documenting a company’s decisions are provided. FDA provides a series of flowcharts and questions that can serve to guide medical device manufacturers to come to a conclusion as to whether a new 501(k) is necessary. The flowcharts address changes to:

  • Labelling
  • Technology, Engineering and Performance
  • Materials
  • Technology, Engineering, Performance and Materials for in vitro Diagnostic Devices

The second FDA guidance addresses proposed changes to software used in conjunction with a medical device. The draft includes modifications made to correct software defects, provide patches or updates to code, and provide enhancements or modifications to functionality. Software manufacturers must determine whether any change or modification could potentially and significantly affect the safety or effectiveness of a device. The first step recommended by FDA is to conduct a risk assessment of the change, including all potential new risks along with known risks for the device. Again, the FDA provides a flowchart to guide software manufacturers through the process of determining whether a 510(k) must be prepared. FDA also provides examples of changes to software, along with an analysis as to why a new 510(k) would or would not be needed.

An official from the US Food and Drug Administration (FDA) says the agency is working to finalize two draft guidance detailing when a new 510(k) is required for changes to medical devices and their software before the 8 November 2017 deadline set by the 21st Century Cures Act.

In August 2016, FDA released the two-draft guidance, five years after the agency’s first attempt to replace its 1997 guidance on the topic. But, FDA withdrew the 2011 draft guidance after Congress ordered the agency to rethink the policies discussed in that version, which industry said would lead to a major increase in the number of changes that would require a new 510(k).

Speaking at RAPS’ 2017 Convergence, Michael Ryan, a regulatory advisor at the Office of Device Evaluation within the Centre for Devices and Radiological Health, said the agency is going through the comments it received on the draft guidance and is working to clarify some of the questions raised by industry and make the terminology used across the guidance more consistent.

Ryan also said the agency is planning to release more device specific guidance to provide examples of changes that would require a new 510(k). But, Ryan said those documents would come after the general guidance are finalized.

According to Ryan, the key questions companies need to consider when evaluating whether a change to one of their devices requires a new 510(k) is if the change could significantly affect the safety or effectiveness of the device. In this context, both the possibility of the change having an impact and its significance are important to making that determination.

Ryan clarified that changes that improve the safety or effectiveness of a device will require a new 510(k), if they have a significant impact on safety or effectiveness.

Whether or not a change needs to be submitted in a new 510(k), Ryan said that device makers should thoroughly document any changes, as cumulative changes to a device over time could eventually lead to a new 510(k) being required.

“The better that documentation is the more helpful it is,” Ryan said.

When submitting a new 510(k), Ryan said device makers should compare the changes to the last cleared version of the device, and not to a predicate device or to changes to the device that were not cleared.

Ryan also said that device makers should include any information on previous changes if that information would help them understand the device or if those details would have been included in the original 510(k).

For instance, individual components on the motherboard in a device, such as a resistor, that were not described in the original submission would not need to be described if the submission did not need to go into that level of detail.

“They only need to be described if they are necessary for the review staff to really understand the device,” Ryan

Another consideration, Ryan said, is if a change made to a device leads to changes in the verification and validation testing for the device, as those changes could require a new 510(k).

But Ryan said that if the change in testing was only to accommodate a changing standard, and not a change in the device itself, then a 510(k) would not likely be required.

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