Apr 21, 2011

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has issued new guidance regarding when medical device firms should issue 30-day notices for manufacturing changes.

The guidance also explains which manufacturing changes instead warrant 135-day premarket approval (PMA) or 75-day Humanitarian Device Exemption (HDE) supplements.

Manufacturing changes that qualify for 30-day notices pertain to changes in manufacturing methods and procedures—unless those changes affect product performance or design specifications, or alter the device’s physical or chemical specifications. In those instances, manufacturers should provide 180-day PMA supplements or 75-day HDE supplements as appropriate.

Examples of manufacturing changes warranting 30-day notice include:

  • Sterilization process parameters
  • Automation of an existing manufacturing process
  • Joining processes
  • Cleaning methods for manufacturing material removal
  • Changes in manufacturing materials such as machine lubricants and soldering flux


Furthermore, such changes should be submitted as 30-day notices only if they’re considered critical to device performance; otherwise, manufacturers should document these changes in their periodic or annual reports.

Changes that do not qualify for 30-day notices include those to manufacturing or sterilization sites of finished devices; to design or performance specifications; to material specifications; or to device operating software.

Once a manufacture has submitted notice, the firm may resume distributing the device in question after the 30-day notice period unless contacted by the FDA for further information.

The CDRH is accepting public comment on the guidance at any time.


  • Stewart Eisenhart