Design & Testing

FDA/​Regulatory

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Learn about FDA medical device regulations and how to achieve approval. Our news and expert advice provides an overview of regulatory requirements for Class I, Class II, and Class III devices.

Latest Briefs & News

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News: Regulations/Standards
In a significant collaboration to help advance pediatric health, Children’s National Hospital and the U.S. Food and Drug Administration’s (FDA) Office of...
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Features: Electronics & Computers
Pulsed field ablation is a nonthermal method of tissue ablation technology that uses high amplitude pulsed electrical fields to create irreversible electroporation in tissues. Read on to learn more about it.
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Briefs: Medical
The changing regulatory landscape and innovation of medical products is driving an interest in additional options for medical product sterilization. Read on to learn what this means.
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Trivia: Regulations/Standards
What government group was formed to study medical devices and recommend legislation, ultimately leading to the 1976 Medical Device Amendments?
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Podcasts: Design
In this season, we are taking an in-depth look at Printed Health: Transforming Medicine with Advanced Manufacturing, and this episode will focus specifically on...
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News: Packaging & Sterilization
As leaders in the medical device industry seek ways to optimize the application of ethylene oxide (EO) sterilization, it is more important than ever to ensure that medical device...
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From the Editor: Regulations/Standards
At the end of June, FDA released a draft guidance that is designed to facilitate and streamline development of stand-alone devices and combination products by improving the consistency of drug-delivery performance information included in applications and submissions. Read on to learn more about it.
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Blog: Government
The global landscape for medical technology, biotechnology, and life sciences is on the cusp of seismic change.
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INSIDER: Regulations/Standards
On Tuesday, February 6 at 12:30 pm, Balazs Boznik, BSEE, Technical Director, Medical Audit, at SGS North America will discuss FDA’s plan to adopt ISO 13485.
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From the Editor: Regulations/Standards
Analytics firm GlobalData has weighed in on the U.S. FDA's proposal to reclassify laboratory-developed tests (LDTs) as medical devices. FDA historically exercised enforcement discretion over LDTs, meaning that it did not actively regulate them like it does for other medical devices, so this is a significant regulatory change.
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Features: Connectivity
ISO 80369 Part 7, the long-awaited replacement to ISO 594, introduced a number of changes to the standard governing dimensions and performance requirements of Luer connectors.
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News: Medical
MasterControl, a provider of quality and manufacturing software solutions for the life sciences industry, has released a new study analyzing five years of product recall data from...
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News: Medical
NuVasive and Zimmer Biomet, both leading innovators in the medical devices industry, have become Pending Subscribers to the MedAccred accreditation program.
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Briefs: Design
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.
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Blog: Regulations/Standards
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.
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News: Medical
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...
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News: Design
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...
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From the Editor: Medical
Written by Katie Falcone, Scientific Support Manager, Datwyler, this article addresses the dangerous implications of micro material contamination.
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Briefs: Medical
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.
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News: Manufacturing & Prototyping
The Performance Review Institute (PRI) has launched a new service designed to help companies improve manufacturing and quality management and improve business...
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News: Medical
Organ transplant developer, Paragonix Technologies has received FDA clearance for its next-generation donor lung preservation system, BAROguard™....
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News: Regulations/Standards
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...
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News: Regulations/Standards
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...
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Briefs: Regulations/Standards
Thanks to artificial intelligence (AI), augmented reality (AR) has long shaped product development across a variety of areas, including the medtech industry.
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Supplements: Materials
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.
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News: Regulations/Standards
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...
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News: Medical
The current U.S. regulatory framework for medical devices under the Center for Devices and Radiological Health (CDRH) includes extensive...
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News: Regulations/Standards
The Performance Review Institute (PRI) has expanded its management systems certification portfolio through the acquisition of SRI Quality System Registrar. SRI is headquartered...
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Features: Design
The Institute for Engineering in Medicine’s Innovation Week highlights events that focus on advances and new directions in medical engineering.
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Ask the Expert

Eric Dietsch on the Benefits of Nitinol Wire
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In collaboration with the Fort Wayne Metals Engineering team, Eric Dietsch focuses on supporting customers with material recommendations, product development, and education. Eric is available to help you and your company with any Nitinol-related questions or needs that you may have.

Inside Story

Inside Story: Establishing Safe EO Sterilization for Medical Devices
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To find out more about the expertise required to establish a safe and effective EO Sterilization for medical devices, MDB recently spoke with Elizabeth Sydnor, director of microbiology for Eurofins Medical Device Testing (Lancaster, PA).

Videos