August 27, 2024- The FDA has issued the draft guidance: Predetermined Change Control Plans for Medical Devices. This draft guidance proposes a policy for predetermined change control plans (PCCPs) and recommendations on the information to include in a PCCP in a marketing submission for a device. The FDA reviews the PCCP as part of a marketing submission for a device to ensure the continued safety and effectiveness of the device without needing to submit additional marketing submissions or obtain further FDA authorization before implementing each modification described in the PCCP. The FDA will host a webinar on September 3, 2024 about the guidance. For comment submissions, please see the docket number FDA-2024-D-2338 at www.regulations.gov by November 20, 2024.