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# Guide on Manufacturing Site Change Supplements
- URL: https://www.fdaweb.com/guide-on-manufacturing-site-change-supplements/
- Published: 2018-12-14T12:00:00.000Z
- Updated: 2026-09-15T00:51:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143044

FDA has released a [guidance](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM467414.pdf?ref=fdaweb.com) entitled “Manufacturing Site Change Supplements: Content and Submission.” The document explains FDA’s current thinking on what constitutes a manufacturing site change and when you should submit a PMA supplement for a site change. It also addresses the documentation that should be submitted in a site change supplement. Additionally, it addresses the general factors FDA intends to consider when determining whether to conduct an establishment inspection prior to approval of a site change supplement.