This post was written by Paul Sheives. 

FDA has released a guidance document entitled “30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes.” The guidance addresses the manufacturing method or process changes FDA believes may qualify for the 30-day notice of changes in manufacture method or processes changes, along with the changes that generally do not qualify. If the 30-day notice is insufficient, the manufacturer must file either a 135-day PMA or a 75-day HDE supplement relating to such changes. In addition, the guidance addresses the content for 30-day notices, FDA action on notices, and exceptions to user fees for 30-day notices.