FDA/​Regulatory

MDR: Regulating Devices That Don’t Have an Intended Medical Purpose

Neither the MDR nor Annex XVI are new. Nevertheless, the entry into force of the common specifications now presents a new situation for manufacturers of devices without an intended medical purpose.

The Consultant, the FDA, and You

Understanding what the FDA really means by their time frames, knowing how to address their regulatory issues, and preparing a response to a 483 or Warning Letter is critical to showing the FDA that you understand what they expect from you and that you will work to bring your company into compliance. Another critical point is to understand that you can negotiate with the agency.

FDA Establishes Advisory Committee on Digital Health Technologies

The U.S. Food and Drug Administration has created a new Digital Health Advisory Committee to help the agency explore the complex, scientific and technical issues related to...

FDA Awards Nearly $7.5 Million to Foster Pediatric Device Development

To foster the development and commercialization of medical devices designed for children, the Food and Drug Administration (FDA) has awarded a nearly $7.5 million grant to...

Guest Editorial

Written by Katie Falcone, Scientific Support Manager, Datwyler, this article addresses the dangerous implications of micro material contamination.

AdvaMed: EPA’s EtO Proposals Create Significant Risk of a Healthcare Crisis

The EPA issued two separate proposals earlier this year covering the use of EtO for device sterilization: the National Emission Standards for Hazardous Air Pollutants and the preliminary interim decision under the Federal Insecticide, Fungicide, and Rodenticide Act.

PRI Launches New Program to Help Companies Improve Manufacturing, Quality

The Performance Review Institute (PRI) has launched a new service designed to help companies improve manufacturing and quality management and improve business...

Paragonix Technologies Receives FDA Clearance for BAROguard Donor Lung Preservation System

Organ transplant developer, Paragonix Technologies has received FDA clearance for its next-generation donor lung preservation system, BAROguard™....

FDA Updates Catalog of Tools to Assess Medical Devices

The U.S. Food and Drug Administration (FDA) updated its Catalog of Regulatory Science Tools by adding four new tools and updating nine others. The catalog is a peer-reviewed resource...

TÜV SÜD Receives UKAB for Medical Devices

TÜV SÜD has received approval as a UK Approved Body (UKAB) for medical devices. With this approval, medical device manufacturers can implement UKCA certification for the UK market and CE...

Artificial Intelligence: Making Innovations Fit for the MDR

Thanks to artificial intelligence (AI), augmented reality (AR) has long shaped product development across a variety of areas, including the medtech industry.

Summer 2023 Resource Guide

In our summer edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.

Windsor Agreement: Changes to Northern Ireland Regulatory Landscape

An agreement reached by the UK and EU regarding the Windsor Framework brings changes to the Northern Ireland regulatory landscape. The agreement , in principle, was reached on...

FDA Pilot Program Supports Streamlined Regulatory Submission Processes for Medical Device Manufacturers

The current U.S. regulatory framework for medical devices under the Center for Devices and Radiological Health (CDRH) includes extensive...

Performance Review Institute Acquires SRI Quality System Registrar

The Performance Review Institute (PRI) has expanded its management systems certification portfolio through the acquisition of SRI Quality System Registrar. SRI is headquartered...

Show Preview: Design of Medical Devices Conference 2023

The Institute for Engineering in Medicine’s Innovation Week highlights events that focus on advances and new directions in medical engineering.

Lifestyle

It's March Madness! What organization was founded by a small group of physical educators and physicians who recognized that health problems were associated with certain lifestyle choices, especially smoking and lack of exercise?

Movano Health to File First FDA Submission for Smart Ring’s SpO2 and Heart Rate Data

Movano Health, Pleasanton, CA, has announced successful preliminary results of its pivotal hypoxia trial, which was completed in conjunction with the...

Winter 2022 Resource Guide

In our summer edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.

Ensuring Regulatory Compliance by Digitizing Change Control in Life Sciences Product Development

Medical device manufacturers face constant changes coming from both internal and external sources.

Education

In November 1848, what was the first medical school to open for women?

Health & Wellbeing

In July 1965, what landmark amendment was passed that helped drive medical innovation and improve the quality of healthcare?

Education

At the turn of the 19th century, what industry was so dangerous that surgeons became specially trained to address the unique injuries of its employees?

Summer 2022 Resource Guide

In our summer edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.

Exploring Valve Technology Requirements Under the New MDR

Although the pandemic has delayed the MDR’s validation date, it has not diminished the importance of this new regulation.

First, Do No Harm: Changing Strategies to Prove Your Medical Device Is Safe

Modern evaluation of biocompatibility uses a risk-based approach.

Establishing Proper Validation of Extruded Silicone Tubing

Bring your project from the process development phase of manufacturing to a fully validated one.

From the Editor - Cybersecurity: Playbook for Threat Modeling Medical Devices

New best practices for understanding medical device security.

Winter 2021 Resource Guide

In our winter edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.