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2024年9月11日 · This draft guidance proposes a policy for predetermined change control plans (PCCPs) and recommendations on the information to include in a PCCP in a marketing …

2023年10月24日 · Recently, the FDA issued a draft guidance proposing Predetermined Change Control Plans, or PCCPs, as a way to ensure that AI/ML-enabled medical devices can be …

2024年8月22日 · The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Predetermined Change Control Plans for Medical …

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 …

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 …

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, …

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 …

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 …

6 天之前 · 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 …