Life Sciences

FDA issues final guidance on submissions of PMA supplements

Device Regulation Alert: Safety, Compliance and Reimbursement News, December 22, 2008

The FDA provided new criteria for medical device manufacturers to determine what type of pre-market application (PMA) to submit for changes involving class III devices.

The new FDA guidance covers proper PMA submission when a manufacturer modifies a device’s:

  • Design or labeling
  • Manufacturing process
  • Location of manufacturing, processing, or packaging

The guidance also applies to modifications made as a result of a recall or field corrective action.

It also provides examples of various types of device modifications, explains what type of testing was performed to support the safety and effectiveness of each device modification, and describes the type of PMA that was submitted.


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