Draft FDA Guidance for 510k device changes

FDA's Center for Devices and Radiological Health announced the release of the draft of the FDA's guidance for 510k device changes.   Jeffrey Shuren, M.D., director of FDA's CDRH, stated that "We are making the regulatory process for medical devices less challenging by better describing our expectations."  "In particular, manufacturers can continue to make innovative improvements to their devices and better plan for any updated submissions. This saves time and money."

Draft FDA Guidance for 510k device changes

 

Draft guidance lays out the kinds of changes that trigger the need for a new submission including:

  • Specific kinds of labeling changes
  • Changes to the technology used in the device
  • Changes in performance specifications
  • Manufacturing process changes
  • Changes in the materials used in the manufacture of the device

This draft guidance is one of 25 action items listed in FDA's Plan of Action for Implementation of 510(k) and Science Recommendations launched in 2011 to enhance predictability,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 programs.

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