IMDRF Releases Key Guidance Documents for Medical Device Software
The International Medical Device Regulators Forum (IMDRF) has released two key guidance documents to support the regulation of medical device software. These include Good Machine Learning Practice for Medical Device Development: Guiding Principles (IMDRF/AIML WG/N88 FINAL:2025) and Characterization Considerations for Medical Device Software and Software-Specific Risk (IMDRF/SaMD WG/N81 FINAL:2025). These documents aim to enhance global regulatory harmonization and assist medical device manufacturers in navigating compliance requirements for software-based and AI-driven technologies.
ANVISA Publishes Database for Clinical Investigations into Medical Devices
The National Health Surveillance Agency (ANVISA) has announced the launch of a database aimed at clinical investigations related to medical devices. This initiative represents an important milestone in the health sector, promoting greater transparency, efficiency and safety in research carried out in Brazil.
Modifications to Container Closure Systems: Glass Vials and Stoppers
The FDA is providing this guidance to compile recommendations for the appropriate reporting categories and the content of post approval change submissions from various FDA guidance documents.
“Electronic Submission Now Available for Investigational New Drug Application (IND) Safety Reports”
The FDA has issued a reminder to drug sponsors and researchers regarding its recent publication of guidance outlining the process for electronically submitting investigational new drug application (IND) safety reports to the FDA Adverse Event Reporting System (FAERS). IND individual case safety reports (ICSRs) can now be submitted electronically through either the Electronic Submission Gateway in ICH E2B (R3) format or via the Safety Reporting Portal, with the FDA now accepting such submissions.
US FDA Publication on Integrating Artificial Intelligence into Healthcare Product
On March 2024, the FDA released its latest publication titled “Collaborative Efforts: Harnessing Artificial Intelligence in Medical Products,” shedding light on the concerted actions undertaken by CBER, CDER, CDRH, and OCP in navigating the landscape of AI integration within the medical product realm. This comprehensive document delineates strategic focal points essential for advancing the application of AI throughout the entire lifecycle of medical products.
FDA-Advancing Real World Evidence Program
On October 2022, the U.S. Food and Drug Administration is announcing the Advancing Real-World Evidence (RWE) Program
The USA FDA updated Electric CPP’s with quick response QR code
Beginning on March 25, 2022, the FDA will be adding a unique quick response (QR) code to electronic Certificates of Pharmaceutical Products (eCPPs)
FDA’s AI/ML Action Plan Includes ‘Tailored’ Regulatory Framework for SaMD
On January 18th 2021, the US Food and Drug Administration (FDA) released a five-part action plan for their artificial intelligence and machine learning (AI/ML) software and classified it as a medical device (SaMD).
TGA announces new fee schedule and delays in proposed regulations
For the fiscal year 2020-2021, TGA (Therapeutic Goods Administration) announces an updated fee schedule which comes in effects from July1, 2020.