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In March 2026, the International Organization for Standardization (ISO) published the fourth edition of ISO 14155:2026, replacing the previous edition from 2020. This is the medical device global reference for GCP conduct that many regulatory authorities recognize. Clinical Pathways offers an ISO 14155 Comparison Tool to support you to do an impact analysis and plan updates to SOPs, templates and tools for your trials.
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The US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) collaborated with the European Medicines Agency (EMA) to develop 10 Guiding Principles of Good AI Practice in Drug Development. They are intended to be a foundational basis for developing good practices with AI, addressing the unique nature of AI, as well as cultivating its future growth.
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In addition to the launch of Elsa, in a press announcement on December 1, 2025, the FDA broadcasted the deployment of Agentic AI capabilities for their employees. Agentic AI is unique from LLM AI due to its capability to plan, reason, and execute multi-step actions in order to achieve a specific goal. This means it can be used to assist with more complex tasks.
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On June 2, 2025, the U.S. Food and Drug Administration (FDA) announced the launch of their Artificial Intelligence (AI) Tool: Elsa. AI has been seen in many parts of the clinical research ecosystem in recent years such as trial and protocol design, participant recruitment, and safety monitoring, all of which have the potential to enhance trial efficiency and safety.
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On December 19th, 2025, the US Food and Drug Administration released the finalized guidance for industry: Processes and Practices Applicable to Bioresearch Monitoring Inspections. The guidance details the processes and practices of Bioresearch Monitoring Program (BIMO) inspections of FDA-regulated establishments NOT specified in existing FDA guides or manuals.
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In March 2026, the International Organization for Standardization (ISO) published the fourth edition of ISO 14155:2026, replacing the previous edition from 2020. This is the medical device global reference for GCP conduct that many regulatory authorities recognize. Clinical Pathways offers an ISO 14155 Comparison Tool to support you to do an impact analysis and plan updates to SOPs, templates and tools for your trials.
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On December 15th, 2025, the US Food and Drug Administration (FDA) released the finalized guidance for industry “Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices”. Unlike most updates, this finalized guidance is replacing the FDA’s recommendations from two separate final guidance documents: “Safety Reporting Requirements for INDs and BA/BE Studies” from 2012 and “Adverse Event Reporting to IRBs—Improving Human Subject Protection” from 2009, both of which are now withdrawn.
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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an appearance in other FDA guidances.
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Medical Devices in the European Union (EU) are regulated by the Medical Device Regulation (MDR) (Regulation EU 2017/745) which supersedes the previous Medical Devices Directive (MDD)( 93/42/EEC). MDR was implemented on May 26th, 2021 with a three-year transition period. MDR requires that all manufacturers of medium to high-risk medical devices be certified by a notified body.
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On September 6, 2023 the US Food and Drug Administration (FDA) issued a bulletin announcing three new draft guidances regarding the FDA’s Center for Devices and Radiological Health’s (CDRH) 510(k) premarket submission program to verify that the medical device to be marketed is substantially equivalent to a legally marketed device as medical devices continue to become more complex and innovative.
