FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Final FDA Guidance Outlines Rules for Manufacturing Site Change Supplements

Dec. 21, 2018
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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.

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