FDA releases final guidance document on PMA manufacturing site change supplements

On 17 December 2018 the U.S. Food and Drug Administration (FDA) issued a final guidance document intended to help manufacturers determine the appropriate premarket approval (PMA) application supplement reporting pathway for implementing changes in the manufacturing sites used for a PMA approved device.

The guidance also includes the required contents of a PMA site change supplement and the general factors that FDA intends to consider when determining whether to conduct an inspection prior to approval of a site change supplement. The final guidance document, "Manufacturing Site Change Supplements: Content and Submission," replaces a 2015 draft guidance document of the same name. The 2015 draft was intended to distinguish when a change to a manufacturing site for an approved PMA requires submission of a 180-day site change supplement versus submission of a 30-day notice for a modification to manufacturing procedures or methods of manufacture. The 2015 draft was written in a Q&A format and provided a table that identified various site change scenarios and FDA's position as to whether such a change required a 180-day site change supplement or a 30-day notice submission. The 2015 draft also provided a table outlining the agency's thinking with respect to when a site change supplement also triggered the need for a preapproval inspection.

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