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FDA 510(k) Application - Generic Medical Devices

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A Premarket Notification [510(k)] is a premarket submission made to FDA to demonstrate the device being marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to Premarket Approval (PMA).The submitter may market the device immediately after 510(k) clearance is granted. Three types of Premarket Notification 510(k) submissions for marketing application: Traditional, Special, and Abbreviated.

Service

  • Organizing and reviewing the original materials and product information
  • Organizing and reviewing manufacturing process and control materials
  • Preparing 510(k) package
  • Submitting 510(k) materials to FDA
  • Correspondence with FDA
  • Routine maintenance of approved 510(k) (Annual report, change report, and notification…)

Link to "Services" for more information.