GS1 Guideline Seeks to Help Implement FDA’s UDI Requirements

USA – GS1 Guideline Seeks to Help Implement FDA’s UDI Requirements

GS1 US recently updated its unique device identification (UDI) implementation guideline, with new instructions on device identifiers (DIs), production identifiers (PIs), human readable information...
EC Seeks Feedback on New and Revised MDR/IVDR Standards

Europe – EU Device Industry Groups Call to Accelerate MDR Implementation

With the EU’s new medical device regulation (MDR) coming into effect in less than a year, seven EU-based medical device industry groups on Wednesday...
NESTcc Taps Apple Watch as First Wearable Project

USA – NESTcc Advances Data Quality and Study Design Frameworks

The National Evaluation System for health Technology Coordinating Center (NESTcc) on Tuesday unveiled two frameworks on data quality principles and study design methods for...
IMDRF Seeks Input on Regulatory Pathways for Personalized Medical Devices

International – IMDRF Seeks Input on Regulatory Pathways for Personalized Medical Devices

In a new proposal to harmonize regulatory pathways for personalized medical devices, the International Medical Device Regulators Forum (IMDRF) is looking to crack down...
FDA Offers Technical Specifications for Submitting NGS Data on Antivirals

USA – US FDA calls for test cases for its SaMD Pre-Cert Program

The US Food and Drug Administration has called for test cases from developers for its nascent Pre-Cert certification program for software as a medical...
Experts Discuss CDRH Proposals That May Require New Authorities

USA – Experts Discuss CDRH Proposals That May Require New Authorities

From a pre-certification (PreCert) approach on software as a medical device (SaMD) and laboratory-developed tests (LDTs) to cybersecurity and the 510(k) premarket review pathway,...
FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections

USA – FDA permits marketing of first diagnostic test to aid in detecting prosthetic...

Today, the U.S. Food and Drug Administration permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for the detection of periprosthetic...
FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies

USA – FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies

Today, the U.S. Food and Drug Administration authorized marketing of a diagnostic test to detect Zika virus immunoglobulin (IgM) antibodies in human blood. The ZIKV Detect...
FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea

USA – FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea

Today, the U.S. Food and Drug Administration cleared for marketing two tests that can detect the presence of the bacteria Chlamydia trachomatis and Neisseria...
Developing a Wearable Display for Surgeons

USA – Developing a Wearable Display for Surgeons

Cameras and screens have been used to augment surgeons’ vision for years, enabling them to see magnified surgical sites for greater precision. But as...

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