FDA Guidance Outlines Rules for Site Change Supplements

Final guidance issued by the FDA on Friday outlines what devicemakers should know about manufacturing site changes and when they should submit supplements.

Applicants should submit a 180-day premarket approval (PMA) supplement for using a different site if the change affects the device’s safety or effectiveness. Humanitarian device exemption (HDE) holders, meanwhile, are required to submit a 75-day supplement.

All site change supplements should clearly identify any changes to manufacturing locations and associated changes to the manufacturing process that result, such as requirements for alterations to the water filtration for manufacturing. If activities being moved are not already conducted at the new manufacturing site, a full supplement is required.

The FDA does not require a PMA supplement in cases where a new facility is used for the manufacture, processing or packaging of a component for a finished device. Companies that manufacture components but not finished devices are not subject to the QS regulation requirements but are “encouraged to use appropriate provisions” of 21 CFR, the agency says.

Applicants should submit 30-day notices for use of new suppliers of any components critical to the finished device’s function, operation or specifications, as those changes may affect the finished device’s effectiveness or safety.

“Manufacturing changes to components that are not critical to the device’s function, operation or specifications do not require firms to submit a site change supplement or a 30-day notice; however, these changes must be reported in the Annual Report,” the guidance states.

The site change supplement should include a description of the device, its intended use, and the nature and purpose of the site change, including a full description of what manufacturing activities will take place at the proposed site. It should also feature a diagram of the proposed new site or sites and a flow diagram laying out the steps involved in the manufacture, processing, packaging or distribution of the device under review at the proposed site.

Read the full guidance here: www.fdanews.com/12-14-18-SiteChangeSupplements.pdf. — Zack Budryk