Part 3 of the “Are You Aloof About OMUFA, MDUFA, and GDUFA?” series. Final installment in a three-part series on FDA user fee programs. Part 1 covered OMUFA, Part 2 covered MDUFA, and this article focuses on GDUFA. GDUFA Is More Than an ANDA Fee...
Part 2 of the “Are You Aloof About OMUFA, MDUFA, and GDUFA?” series. This is the second installment in a three-part series on FDA user fee programs. Part 1 covered OMUFA, and Part 3 will address GDUFA. MDUFA Is More Than Just a Submission Fee ...
Part 1 of the “Are You Aloof About OMUFA, MDUFA, and GDUFA?” series. This is the first installment in a three-part series examining FDA user fee programs affecting OTC drugs, medical devices, and generic drugs. Part 1 covers OMUFA. Part 2 will address...
The global Unique Device Identification (UDI) landscape is entering a critical enforcement phase — and 2026 will be a challenging year for medical device manufacturers operating in the European Union, Australia, and Switzerland. Health authorities are migrating...
UDI product data is now due for specific scenarios (enforced as of December 8, 2022). Class I and Unclassified medical devices that are required to be labeled with a UDI code must submit product data to the FDA GUDID — the enforcement date began December...
Swissmedic has launched the Unique Device Identification (UDI) module within the swissdamed database (Swiss Database on Medical Devices) . Since August 2025, manufacturers, importers, and authorized representatives can voluntarily submit medical devices, systems...
FDA updates guidance on GUDID and GMDN codes: what manufacturers need to know The FDA has introduced significant updates impacting the medical device industry, specifically targeting Global Medical Device Nomenclature (GMDN) Codes compliance in the Global Unique...
UDI labeling best practices for medical device manufacturers Unique Device Identification (UDI) labeling remains a hot topic among medical device manufacturers under pressure to comply with UDI requirements for US FDA GUDID and other emerging health authorities...
UDI regulations: global updates from 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...
EUDAMED now or later? UDI/Device registration strategy for manufacturers With the EUDAMED go-live date rescheduled multiple times, manufacturers face conflicting strategies of when to make UDI/Device registration submissions to EUDAMED. Though a few may ignore...
EU proposed legislation and EUDAMED rollout On January 23, 2024, the European Commission proposed a legislative amendment to address two major issues in the EU Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). We asked our in-house...
By submitting product data to health authority data bases, the medical device industry can help ensure safety and traceability for devices. One crucial element is the European Commission/EUDAMED-specific concept of Basic Unique Device Identifier – Device...
EUDAMED timeline update: what medical device manufacturers need to know Understanding EUDAMED EUDAMED is an online system that aims to centralize and harmonize the data related to medical devices across the European Union. It is a vast repository containing...
The U.S. Food and Drug Administration (FDA) recently initiated two initiatives to improve the completeness and quality of the Global Unique Device Identification Database ( GUDID ). As a medical device manufacturer or other organization responsible for reporting...
Horsham, Pa., USA – February 24, 2022 – In response to the needs expressed by medical device manufacturers for ways to effectively manage the product lifecycle from conception through regulatory clearance and post-market activities, LexisNexis Life...
UDI: how to assign device identifiers for GUDID As you work on implementing UDI, you may be wondering how to assign the Device Identifier (DI) portion of the UDI to your products and how to make sense of the different levels of DIs in a single GUDID record. These...
How does software as a medical device relate to unique device identification? Determining software as a medical device It is critical to first determine if the software article is a Device Component, a Device Accessory, or a Standalone Device. A Device...
The European Union (EU) requires manufacturers to supply ‘implant cards’ for patients with implanted medical devices, as prescribed in Article 18 of Regulation (EU) 2017/745 on medical devices. The requirement’s purpose is to give patients easy...
How a global respiratory solutions provider transformed UDI compliance with LexisNexis Life Sciences Solutions Our customer is a global respiratory solutions provider, dedicated to supporting and improving the lives of patients. With several acquisitions over...
Summary of the Emergo webinar presented by Kenji Yashiro: Medical Device Regulatory Requirements – Japanese Guidelines Key takeaways This blog will cover just a few high-level takeaways from the presentation by Kenji Yashiro, hosted by Emergo. While there...