FDA update – April 15 2011

FDA publishes new guidance on: 30-Day Notices, 135, PMA Supplements and 75-Day HDE Supplements for Manufacturing Method or Process Change

The Food and Drug Administration (FDA) has announced the availability of the guidance entitled 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes.

This document provides guidance on

  • The type of changes to an approved application that FDA believes may qualify for submission as 30-day notices
  • Type of changes that do not qualify for 30 day notices.
  • The type of information to submit in a 30-day notice,
  • The user fees associated with these submissions.

This guidance is being implemented without prior public comment because the Agency has determined that prior public participation is not feasible or appropriate.

This guidance supersedes the previous guidance document entitled 30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes, Guidance for Industry and CDRH that published in the Federal Register of February 25, 1998 (63 FR 9570).

The previous guidance did not include information on HDEs even though certain modifications to a manufacturing procedure or method of manufacture for HDEs are subject to the 30-day notice provisions.

Food, Drug, and Cosmetic Act (the Act) provides that PMA supplements are required for any change to a device subject to an approved application that affects safety or effectiveness, unless such change is a modification in a manufacturing procedure or method of manufacturing.

The Act states that changes in manufacturing procedures or method of manufacturing that affect safety or effectiveness require a 30-day notice. Where FDA finds such notice inadequate, FDA will inform the applicant that a 135-day PMA supplement or 75-day HDE supplement must be submitted.

For more information on this issue you can go to the following link:http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080194.pdf  or contact mdi at info@mdiconsultants.com REF: guidance on 30 day notices.