Los Angeles, CA – Bridging Consulting is proud to announce the publication of a guest column by Yu Zhao, founder of Bridging Consulting, on two prominent industry platforms: Drug Delivery Leader and Med Device Online. The article, titled "Decoding The FDA's Final Guidance On PCCPs For AI-Enabled Device Software Functions," provides an in-depth analysis of the FDA’s December 2024 Final Guidance on Predetermined Change Control Plans (PCCPs) and its implications for AI-enabled device software functions and combination products.
Key Highlights of the Article:
A detailed comparison between the December 2024 Final Guidance and the April 2023 draft guidance.
Critical considerations for leveraging PCCPs to manage modifications to device constituents of combination products.
Insights into how the guidance impacts the development and regulation of AI-driven medical devices.
Practical takeaways for manufacturers aiming to streamline regulatory pathways and foster innovation.
📖 Read the full article on Drug Delivery Leader here.
📖 Read the full article on Med Device Online here.
“The FDA’s Final Guidance on PCCPs marks a pivotal step in regulating AI-enabled healthcare innovations,” said Yu Zhao. “I’m thrilled to share insights on how this guidance can support manufacturers in balancing safety, efficacy, and speed to market.”
The article underscores Bridging Consulting’s commitment to thought leadership and providing actionable strategies for navigating the complex regulatory landscape.
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