An official from the US Food and Drug Administration (FDA) says the agency is working to finalize two draft guidances 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 twodraft guidances, 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 But, FDA withdrew the 2011 draft guidance after Congress ordered the agency to rethink the policies discussed in that version, which industry said would lead to a major increase in the number of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 Center for Devices and Radiological Health, said the agency is going through the comments it received on the draft guidances and is working to clarify some of the questions raised by industry and make the terminology used across the guidances 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 guidances 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.