FDA News USFDA Final Guidance – Manufacturing Site Change Supplements: Content and Submission


Although this is only for facilities with existing PMAs, there is a tiny bit of new information on how the FDA views establishments, facilities and the inter-relation between the two.

This guidance uses the term “site” to encompass both establishments and facilities. “Establishment” and “facility” are not defined in 21 CFR Part 814. For purposes of this guidance, FDA is using the term “establishment” as defined in 21 CFR 807.3(c), which means a place of business under one management at one general physical location at which a device is manufactured, assembled, or otherwise processed. FDA is defining the term “facility” for purposes of this guidance to mean the physical structures or buildings within an “establishment.”
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