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30 Days Into the U.S. Government Shutdown: What It Means for the FDA and for You
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Recent Blogs
How a Government Shutdown Impacts the FDA and Healthcare Industry
A government shutdown forces the FDA to scale back operations, delaying new drug and device approvals and slowing healthcare innovation. Learn what continues, what pauses, and why prolonged disruptions matter for patients and providers
Swissmedic Launches UDI Module in swissdamed
Swissmedic has launched the UDI module in swissdamed, marking a key step in Switzerland’s medical device regulation. Voluntary submissions begin in August 2025, with mandatory registration starting July 2026. The system aligns with EUDAMED standards to enhance traceability, compliance, and post-market surveillance.
Navigating the TGA’s Phased Introduction: What Class III & IIb Device Sponsors Need to Know
Australia’s Therapeutic Goods Administration (TGA) is taking a phased approach to regulatory compliance, prioritizing higher-risk medical devices first and gradually expanding requirements to lower-risk categories in the coming years. This structured rollout is designed to manage the complexity of implementation while ensuring that patients and healthcare systems benefit from stronger safeguards at the earliest possible stage.
FHIR and the Future of Labeling
Learn how manufacturers can adopt FHIR to modernize labeling, enhance traceability, and meet evolving regulatory expectations.
EUDAMED Rollout Delay: What It Means for Medical Device Manufacturers
The European Commission (EC) has missed a key milestone in the rollout of EUDAMED, the central database for medical devices in the EU. According to the previously published timeline, EUDAMED was expected to be declared “fully functional” by July 1, 2025. However, with that date now passed and no notice published in the Official Journal of the European Union (OJEU), the official timeline remains unmet.
Regulatory Survival Guide: FAQs Every Drug and Medical Device Manufacturer Should Know
Navigating drug and device regulations isn’t optional—it’s mission-critical. This Regulatory Survival Guide breaks down the complexities of global compliance, from FDA and EU MDR to Health Canada, UDI, and MoCRA. Whether you’re managing submissions or facing upcoming deadlines, use this FAQ to decode key terms, avoid costly risks, and stay ahead with expert-backed solutions like Compliance-as-a-Service (CaaS).
FDA Updates Guidance on GUDID and GMDN Codes: What You Need to Know
Explore the FDA’s update on GUDID, focusing on the transition to GMDN Codes for device identification. Learn how to adapt to these changes efficiently.
EUDAMED Questions Answered; Navigating the Gradual Roll-Out of EUDAMED under MDR and IVDR Updates
Last week, the European Commission released a Q&A on practical aspects related to implementing the gradual roll-out of EUDAMED. In the following blog, we will cover highlights from the document and recommendations for the next steps.
LexisNexis Reed Tech and 1WorldSync Webinar Recap: Leveraging UDI and GDSN
On Tuesday, October 15, 2024, Reed Tech and 1WorldSync hosted a highly informative webinar led by Gary Saner, Senior Regulatory Principal at Reed Tech, and Scott Brown, Senior Director of Global Data Strategy at 1WorldSync. The webinar focused on how their continued alliance helps companies navigate Unique Device Identification (UDI) management and utilize the Global Data Synchronization Network (GDSN) to meet regulatory compliance requirements.