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Recent Blogs
UDI Regulations from EUDAMED, MDR, FDA, and other Global Health Authorities
In recent years, Unique Device Identification (UDI) regulations have been a focus topic for global health authorities. These regulations enhance patient safety, improve supply chain management, and facilitate efficient medical device recalls. Read on for a recap of recent updates and expected changes to UDI regulations from global health authorities.
Takeaways from RAPS Convergence 2024: Navigating the Evolving Landscape of Medical Device Regulations and Digital Transformation
Navigating the Evolving Landscape of Medical Device Regulations and Digital Transformation
Effective 10/1/24, New FDA Requirements for Listing OTC Monograph Drugs in eDRLS
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) has introduced reforms to the OTC drug review process. Starting October 1, 2024, the listing of OTC monograph drug products will require the use of the current Marketing Category and Application Number values in the FDA’s Electronic Drug Registration and Listing System (eDRLS), and will not be able to be certified under the old marketing categories and old application number fields.
LexisNexis® Reed Tech® and 1WorldSync enable Global Medical Device Manufacturers to Manage Regulatory UDI submissions and Product Data Syndication
LexisNexis® Reed Tech® and 1WorldSync enable Global Medical Device Manufacturers to Manage Regulatory UDI submissions and Product Data Syndication. The collaboration pairs Reed Tech SingleSource™ for Medical Devices, which provides UDI regulatory data management technology, with 1WorldSync’s Global Data Synchronization Network (GDSN) capabilities. This allows MedTech companies to centrally manage and share product data required by global health authorities, customers, and stakeholders. The alliance assists the medical device industry in providing product information to regulatory systems, retailers, healthcare providers, and consumers, offering a comprehensive product data solution.
UDI Implementation Tips and GDSN Data Management
Tracking and Tracing Medical Devices: 4 Ways to Simplify Your UDI and GDSN Data Management Tracking medical devices...
Discontinuation and Relisting Features added to MoCRA
The U.S. Food and Drug Administration (FDA) has recently announced the release of two new features for cosmetic product registration and listing. These new Modernization of Cosmetics Reform Act of 2022 (MoCRA) features are designed to simplify the process of managing cosmetic product information for responsible persons.