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Home » FDA says change control draft guidance could force rewrite of when-to-file guidances
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FDA says change control draft guidance could force rewrite of when-to-file guidances

April 24, 2023
By Mark McCarty
The U.S. FDA’s draft guidance for predetermined change control plans (PCCPs) is a groundbreaking guidance that was enabled by legislation that allows the filing of PCCPs with all device types, not just software as a medical device (SaMD). However, a member of the FDA team acknowledged recently that this new approach to device change management could require that the agency revisit existing guidances such as a guidance for when to file a new regulatory submission for 510(k) devices, thus heralding a series of guidance revisions that may take several years to unwind.
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