FDA Updates Guidance Document Regarding Changes that Qualify for a 30-Day Notice

By Carmelina G. Allis –

Earlier this month, FDA updated the 1998 guidance document regarding changes to a PMA device that may or may not qualify for a 30-Day Notice.  This updated document provides new examples of manufacturing changes that may be submitted under a 30-Day Notice and reflects the current review process for those submissions.  In addition, information regarding user fees for 30-Day Notices has been included.

The updated guidance recommends that a 30-Day Notice be submitted for changes in manufacturing procedures or methods of manufacture that affect the safety or effectiveness of PMA devices, or that are critical to the performance of the device.  If the changes do not affect safety or effectiveness, or are not critical to the performance of the device, then they may be submitted in a PMA annual report.

Some examples of changes that FDA says may be appropriate for a 30-Day Notice include:

• sterilization process parameter changes (e.g., dose auditing or aeration time);
• changes from manual to automated processes;
• changes in manufacturing materials, such as machining lubricants; or
• a change in sterilization test site. 

Other changes appropriate for a 30-Day Notice include changes to quality control testing used on incoming or raw materials or a finished device, as well as changes in manufacturing processes, such as a change from machining to injection molding of a part.  The new guidance also suggests that a change in raw material supplier qualifies for a 30-Day Notice as long as the change does not result in a modification to device component specifications.

The new guidance also addresses those changes that are not appropriate for a 30-Day Notice, such as changes in the manufacturing procedure or method of manufacture that alter the performance, design, physical, material, or chemical specifications of the device.  In addition, changes in the manufacturing/sterilization site or device operating software are not appropriate for 30-Day Notices.  Most importantly, labeling changes do not qualify for a 30-Day Notice.  If a change does not qualify for a 30-Day Notice, FDA recommends that the manufacturer submit a 180-day PMA supplement or another alternate submission.

After submission of a 30-Day Notice, the manufacturer can distribute the product 30 days after the date on which FDA received the notice, unless FDA notifies the manufacturer within those 30 days that the notice is inadequate.  If the information is deemed inadequate, FDA will notify the manufacturer in writing that a 135-Day PMA supplement is required, in which case the letter will also indicate the additional information required to evaluate the change.

The new guidance, “Guidance for Industry and FDA Staff; 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes,” was issued on April 13, 2001, and is available here.