Manufacturing Site Change Supplements: Content and Submission - Draft Guidance for Industry and FDA Staff

www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM467414.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

A draft guidance has been posted titled, "Manufacturing Site Change Supplements: Content and Submission."  This draft guidance explains FDA’s current thinking regarding the following:

(A) What constitutes a manufacturing site change and when you should submit a PMA supplement for a site change;
(B) What documentation you should submit in a site change supplement; and
(C) The general factors FDA intends to consider when determining whether to conduct an establishment inspection prior to approval of a site change supplement.

This draft guidance document replaces an earlier draft guidance entitled “Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval,” issued August 5, 1999.