The US Food and Drug Administration (FDA) has announced that it may release finalised guidelines for the device changes that would need a new 510(K) submission before 8th November, 2017. Rooting to the guidance documents released in 2016 and to clarify some of the questions raised through the comments received, the aim of the recent FDA announcement is to make the terminology consistent by providing precise examples. While the FDA is outlining the changes to devices and their software that require new 510(k) submissions, to simplify the understanding here we give you a few noteworthy points for consideration.

  • Document all cumulative changes even in the absence of the need for 510(K) which may eventually be required
  • Compare the changes to the last cleared version and not to a non-cleared one
  • Include the information about all previous changes those were included in the original 510(K) and which might help understanding the change

The device may require a new 510(K) if,

  • it has a significant impact on safety or effectiveness of the device
  • the device change leads to changes in the verification and validation testing
  • the software modifications trigger additional unintended or unplanned consequences

The device may not require a new 510(K) if,

  • the change in testing was only to accommodate a changing standard, and not a change in the device itself
  • the distributors are marketing other manufacturer’s device under their company name
  • the change to software only restores the device to the specifications of the most recently cleared device

Apart from the above discussed details, there are other cases that could trigger a 510(K) submission. Depending on the device classification, changes can be further classified. Decode the right reason whether you need a submission or not and market your device without hassles. If you are interested in decoding the details on medical device registrations and Regulatory approaches in the Middle East and Mexico, consider going through these archived Webinar presentations. Be Compliant.



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