FDA releases draft guidance on device changes that require new 510(k)

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The Food and Drug Administration (FDA) has released a draft guidance to clarify when changes or modifications to a previously cleared 510(k) device require a new premarket submission.

According to the FDA, manufacturers make device modifications after clearance such as incorporation of new technology or upgrades, however, if the changes affect significantly the product’s safety or effectiveness or constitute a major change to the intended use of the device, another 510(k) must be submitted.


Specific kinds of labeling changes, changes to the technology used in the device, changes in performance specifications, manufacturing changes, and changes in the materials used in the manufacture of the device are part of the clarifications included in the FDA’s draft guidance.


“We are making the regulatory process for medical devices less challenging by better describing our expectations” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “In particular, manufacturers can continue to make innovative improvements to their devices and better plan for any updated submissions. This saves time and money.”


This draft guidance is one of the 25 action items listed in the FDA’s Plan of Action for Implementation of 510(k) and Science Recommendations launched in 2011 to enhance predictability, consistency, and transparency of the FDA’s premarket review programmes.