Discover key regulatory updates from the week of December 2nd in medical devices, IVD, SaMD, pharmaceuticals, biotech, and combination products, as recognised by the Global Index powered by Hoodin. This edition highlights top regulatory news and analyses, featuring updates from two interesting updates from FDA (US). One regarding the Draft Guidance on Accelerated Approval of Drugs and Biologics and the other is the Guidance for Industry, Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions.
Global Reg Index by Hoodin
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Top Picks for December 2nd - December 8th
Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry FDA Published Dec 4
North America | PHARMACEUTICALS | BIOTECH | COMBINATION PRODUCTS
SUMMARY
The FDA has released draft guidance on its Accelerated Approval program, aimed at expediting the development and review of drugs and biologics for serious or life-threatening conditions. It outlines eligibility criteria, standards, and procedures for approval and withdrawal. Comments are open until February 4, 2025.
Key Implications:
Streamlined Pathway for Critical Therapies: The draft guidance emphasises the accelerated approval program for drugs and biologics addressing serious or life-threatening conditions, offering life science companies a faster path to market, particularly in oncology, rare diseases, and other high-priority areas.
Framework for Compliance and Innovation: It provides clear criteria and procedures for accelerated approval, enabling companies to design development programs that align with FDA expectations while maintaining regulatory compliance.
Strategic Planning Advantage: By understanding the standards and withdrawal mechanisms outlined, companies can proactively manage risks, enhance development efficiency, and reduce approval timelines, positioning themselves to meet urgent medical needs effectively.
Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions; Guidance for Industry
FDA | Published Dec 6
North America | MEDICAL DEVICES | IVD | COMBIANTION PRODCUTS
SUMMARY
The FDA has issued final guidance on marketing submissions for AI-enabled device software functions. It outlines requirements for a Predetermined Change Control Plan (PCCP) to manage planned AI software updates. This ensures safety and effectiveness without repeated submissions, fostering innovation.
IMPLICATIONS:
Streamlined Regulatory Path for AI Modifications: The guidance provides a clear process for managing AI-enabled software updates via a Predetermined Change Control Plan (PCCP), reducing the need for repeated submissions while ensuring compliance and patient safety.
Enhanced Product Lifecycle Management: By predefining and validating anticipated modifications, companies can efficiently implement AI updates, fostering innovation and responsiveness to evolving healthcare needs.
Strategic Advantage for SaMD and AI-Integrated Devices: Understanding and utilising PCCP requirements allows companies to stay ahead in a competitive market by ensuring regulatory readiness and minimising delays associated with approval of AI-driven enhancements.
Future-Proofing AI Compliance: With AI likely to be integral to most medical devices in the next few years, adopting these recommendations now positions companies to manage regulatory expectations and technological advancements effectively.
* Top picks may not be the biggest news, as those updates might have already reached you. Instead, the top picks highlight the most important developments for key players in the life sciences industry that you may have missed during the week.
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