Emergo by UL News

Mar 9, 2022

Emergo by UL Launches Digital Human Factors Engineering Platform for Medical Device Manufacturers

Emergo by UL, a global medical device and healthcare technology consultancy, has launched a web-based platform, Optimal Product Usability Suite™ (OPUS).

Mar 6, 2022

Developing and Expanding In-House Human Factors Engineering Capability

OPUS™ digital access to human factors engineering (HFE) tools to enhance medical product safety, effectiveness and ease of use. Learn more at Emergo by UL Human Factors Research & Design.

US FDA medical device user fees see modest increase for 2022

Mar 6, 2022

How Long is the FDA Review Process for 510(k) Medical Device Submissions?

US FDA provides communication timeline for 510(k) reviews in accordance with MDUFA III performance goals.

Proposed US FDA program targets medical device supply chain shortages

Mar 5, 2022

Options for Medical Device Companies to Appeal US FDA Regulatory Reviews and Decisions

FDA guidance outlines appeal options for medical device industry stakeholders disputing regulatory decisions and actions by the Center for Devices and Radiological Health (CDRH). Learn more at Emergo by UL.

Feb 25, 2022

US FDA Formally Proposes Aligning Quality System Regulations with ISO 13485

Proposed rule from US Food and Drug Administration harmonizes 21 CF Part 820 to ISO 13485 quality management system standard for medical devices.

Feb 23, 2022

US FDA Rolls Out Notification Requirements to Protect Medical Device Supply Chains

New US FDA guidance on notifications of medical device discontinuation or supply disruption during public health emergencies.

Feb 15, 2022

Wiklund's Perspective: HFE Consultancies Provide Crucial Support to HFE Teams Embedded Within Medical Technology

As more and more medical technology developers view human factors engineering (HFE) as a core competency, how are HFE consulting providers affected?

Feb 11, 2022

New Guidelines from Japanese Regulators Cover Medical Device Cybersecurity, Remanufactured Devices and MDSAP Reports

Latest guidelines from Japan MHLW and PMDA address medical device cybersecurity, remanufactured devices and MDSAP applications. Learn more at Emergo by UL.

Feb 11, 2022

US FDA Roundup: Final Rules for Combination Products, Patient Reports for Medical Device Evaluation

Medical device manufacturers and sponsors, learn more at Emergo by UL about FDA rules on combination products; patient input on medical device evaluations and clinical studies so you can get to market approval faster.

Feb 9, 2022

IVDR Watch: Updated Joint Implementation Plan Targets Risk of IVD Shortages

An updated IVDR joint implementation plan addresses risks to European IVD supplies due to compliance and capacity issues. Learn more about EU IVD regulations at Emergo by UL.

New Brazil INMETRO ordinance eases inspection and documentation requirements

Jan 28, 2022

Brazilian Regulators to Allow Sales of COVID-19 Self-Test Kits to Consumers

Brazil's ANVISA offers expedited registration for coronavirus self-test kits for consumer use. Learn more at Emergo by UL.

Jan 28, 2022

COVID-19 Pauses US FDA Inspection Plans, Again

The Food and Drug Administration has extended its remote inspection policy for pharmaceutical, medical device and other healthcare product manufacturers as the COVID-19 public health emergency persists.

Jan 18, 2022

US FDA Readies Transition Plans for COVID-19 Medical Device Enforcement Policies

New guidance from the US Food and Drug Administration explains a phased transition plan for medical devices currently covered by agency enforcement policies devised to address the COVID-19 public health emergency.

European Commission issues MDR factsheet for Class I medical device manufacturers

Jan 14, 2022

New Notified Body Designated to IVD Directive in Europe

A second Polish Notified Body, CeCert, has been designated under the European In-Vitro Diagnostic Medical Devices Directive (IVDD).

Jan 11, 2022

US FDA Lays Out Post-COVID EUA Transition Plans for Medical Devices

US FDA publishes new guidance on timelines and related requirements for emergency use authorization (EUA) terminations for medical devices and IVDs following COVID-19 emergency resolution. Learn more at Emergo by UL.

Placing medical devices on the Swiss market after the EU MDR Date of Application

Dec 30, 2021

Medical Device Direct Imports to Users in Switzerland

Swiss regulators develop importation plan for medical devices

Dec 17, 2021

Annex XIV of the European MDR and Clinical Development Plans for Medical Devices

The European medical devices regulation (MDR) requires manufacturers to establish clinical development plans (CDP). Learn more about EU MDR requirements at Emergo by UL.

Dec 14, 2021

US FDA Seeks Stakeholder Comment on Regulatory Approaches to 3D Printed Medical Devices

US FDA issues potential regulatory framework for 3D printed medical devices at the point of care (PoC). Learn more about FDA's approach to 3D printed medical devices and additive manufacturing at Emergo by UL.

Dec 5, 2021

Canadian Regulators Issue New Reporting Requirements for Medical Device Shortages

Canadian regulators explain reporting content, timeframes and related elements of new regulations coming in March 2022 to better manage medical device supply shortages.