Emergo by UL News

Proposed US FDA program targets medical device supply chain shortages

Nov 30, 2021

Five Tips to Make the Most of Your Human Factors Validation Protocol Pre-Sub to the US FDA

How medical device and drug companies can take full advantage of presubmission consultations with the US Food and Drug Administration regarding HF validation test protocol reviews.

Nov 16, 2021

China Update: IVD Classification Rules, Medical Device Self-testing Requirements

Chinese regulators issue new IVD classification rules based on CFDA and IMDRF efforts, plus requirements for self-testing and self-inspection for medical device registrants

Nov 16, 2021

IVDR Watch: European Regulators Update Implementation Framework

Regulators in Europe have updated their implementation plan for sweeping new in-vitro diagnostic (IVD) medical device regulations taking effect in 2022.

Nov 10, 2021

The Modern Era of Potential Use Error

Our Human Factors Research & Design team examines how smart technologies found in medical devices, consumer products and vehicles has introduced new user risks. Learn more at Emergo by UL's HFR&D division.

Nov 9, 2021

New US FDA Guidance Provides Content Recommendations for Medical Device Software Premarket Submissions

The US Food and Drug Administration has published new draft guidance recommending documentation to include in premarket submissions for medical devices that use software.

Nov 2, 2021

Regulators Issue Good Machine Learning Practice Guiding Principles for AI/ML Medical Device Development

Recommendations for developing and testing AI/ML models for medical devices, from US FDA, UK MHRA and health Canada. Learn more at Emergo by UL.

Oct 28, 2021

US FDA Maps Out Medical Device Regulatory Guidance Planned for 2022

FDA center for devices and radiological health (CDRH) plans to publish guidance covering SaMD, postmarket surveillance, emergency use authorization (EUA) transitions, and more.

Oct 25, 2021

European Regulators Offer New MDR Compliance Guidance for Legacy Medical Devices

European MDCG guidance identifies MDR compliance requirements for legacy devices based on task force report

Oct 20, 2021

Defining Critical Tasks for Human Factors Validation Tests of Combination Products

FDA Center for Drug Evaluation and Research (CDER) has different expectations regarding HF validation testing of combination products than the agency's Center for Devices and Radiological Health (CDRH).

Oct 18, 2021

US FDA Roundup: Final De Novo Rule, GUDID for Class I Medical Devices, Reclassification of Surgical Staples

US regulators have issued final rules for de novo novel device classification requests and up-classification of surgical staplers, as well as updated GUDID submission requirements for some class I devices. Learn more at Emergo by UL.

Phased implementation timeframes for European IVDR compliance

Oct 14, 2021

European IVDR Application Partially Postponed

European Commission proposes staggered IVDR compliance timelines to address various implementation challenges.

Oct 11, 2021

Eudamed Update: Additional Data Entry Modules Now Online for European Medical Device, IVD Registrants

European Commissioners have launched additional modules for the Eudamed medical device and in vitro diagnostic (IVD) product database developed to improve European market transparency.

Oct 11, 2021

Japanese Regulators Extend Medical Device Single Audit Program (MDSAP) Pilot

Updated Japan MHLW requirements for MDSAP report submissions take effect in April 2022

Oct 1, 2021

China Update: Clinical Evaluation Authority, Plus Guidelines for Animal Testing Studies

Chinese regulators plan new unit for clinical evaluation efforts, as well as revise animal testing study guidelines for medical device registrants. Learn more at Emergo by UL.

Sep 28, 2021

Considering the Effect of Instructional Text’s Readability on Task Completion Times

Our Human Factors Research & Design (HFR&D) team examines the need for effective instructional text readability for safe use of medical devices, IVD devices and combination products.

A person with a pen holding a checklist.

Sep 24, 2021

Learning Management System (LMS) Reporting: Formatting for Regulatory Audits

What to look for in life sciences LMS reporting features to meet requirements of FDA and other regulatory auditors and inspectors. Learn more about LMS technologies at ComplianceWire.

Sep 24, 2021

US FDA Rolls Out List of Registered Medical Devices Featuring Artificial Intelligence and Machine Learning

FDA regulators have published a searchable list of medical devices incorporating artificial intelligence and machine learning (AI/ML) to promote transparency. Learn more about US FDA regulations at Emergo by UL.

Sep 22, 2021

Emergo by UL’s HFR&D Team: A Melting Pot of Backgrounds and Skillsets

Diversity of expertise, education and backgrounds drives our Human Factors Research & Design (HFR&D) division. Learn more at Emergo by UL.

Sep 20, 2021

Australia TGA to Accept CE Mark Conformity Assessments for Some High-Risk Medical Devices, IVDs

The therapeutic goods administration (TGA) will accept conformity assessments from European notified bodies for some Class III medical devices, active implantable devices and Class 4 IVDs submitted for registration in Australia. Learn more at Emergo by UL

UK MHRA seeks public comment on 2023 medical device, IVD regulatory updates

Sep 19, 2021

UK Regulators Issue New Consultation on Updated Medical Device Regulations Slated for July 2023

UK MHRA seeks public comment on 2023 medical device, IVD regulatory updates

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