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Final FDA Guidance on When Medical Device Changes Require New 510(k) Submissions

 US Food and Drug Administration have published final guidance explaining when changes to registered devices warrant filing new 510(k) premarket notifications to the agency.

The draft guidance for covering changes to a registered device’s hardware and software that necessitates new 510(k) clearance was released in August 2016, following the release of the final guidance there are no major changes from the previous draft.

Changes that may require new 510(k) filings

  • Any hardware change intended to improve a device’s safety or effectiveness requires a new 510(k) application.
  • Changes to labelling; technology, engineering or performance; or materials may also require new premarket notification submissions.

For device software, FDA requires submission of new 510(k) applications in the following instances:

  • Change introduces a new risk or modifies an existing risk that could potentially result  in significant harm.
  • Change causes the need for a new risk control measure or modification to a current control measure to address a potentially dangerous situation that could cause significant harm
  • Change significantly affects clinical functionality or performance specifications directly tied to the device’s intended use

If you need support creating, submitting or keeping track of your 510(k)’s reach out to our experts or view a demonstration of our product please reach out to us on [email protected] or call the team on +44 1244 287 900.


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