2024年12月3日 · Marketing Submission Recommendations for Predetermined Change Control Plans for AI/ML-Enabled Device Software Functions

2024年9月11日 · This draft guidance proposes a policy for predetermined change control plans (PCCPs) and recommendations on the information to include in a PCCP in a marketing submission for a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.

2023年10月24日 · Recently, the FDA issued a draft guidance proposing Predetermined Change Control Plans, or PCCPs, as a way to ensure that AI/ML-enabled medical devices can be safely, effectively,...

2024年8月22日 · The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Predetermined Change Control Plans for Medical Devices." A predetermined change control plan (PCCP) is the documentation describing what modifications will be made to a device and how...

2024年12月13日 · 12月4日，FDA发布了一份重磅指南：《人工智能驱动设备软件功能预定变更控制计划的市场提交建议》（以下简称“PCCP指南”）。 该指南旨在为含人工智能（AI）软件功能的医疗器械提供清晰的变更管理框架。

2024年8月20日 · In December 2022, the Food and Drug Omnibus Reform Act of 2022 provided the FDA with new authority related to the authorization of Predetermined Change Control Plans (PCCPs). A PCCP can enable significant planned modifications to be made to a medical device after the device and the plans to modify the device have been reviewed by the FDA.

2024年8月23日 · Under Section 515C of the FD&C Act, FDA may clear or approve a PCCP that describes planned changes to a device, so long as the device remains safe and effective and, for Class I or II devices, substantially equivalent to the predicate device.

On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence-enabled software functions (the “Final Guidance”).

2024年5月9日 · Ketryx has built an in-depth PCCP template for manufacturers and companies looking to produce an FDA-compliant PCCP. This template explains the step-by-step instructions and procedures for each of the three components of the PCCP (Description of Modifications, Modification Protocol, Impact Assessment) along with an example product.

2025年3月25日 · The FDA outlines three essential components that manufacturers must include in a PCCP. The first is a Description of Modifications, which requires manufacturers to define anticipated changes, including their scope and alignment with the device’s intended use.