Design & Testing

FDA/​Regulatory

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.

Stories

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Products: Materials
New Products and Services
Linear stepper stages, tubing, Bluetooth modules, and more.
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Briefs: Design
Mastering the UKCA Compliance Challenge
Deadlines are approaching for compliance.
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Features: Mechanical & Fluid Systems
Inside Story: Watson-Marlow Fluid Technology Group
Rodd Turnquist tells Medical Design Briefs how to select the best pumps for medical devices and accelerating time to market.
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Supplements: Mechanical & Fluid Systems
Summer 2021 Resource Guide
Our 2021 Resource Guide shows you the top manufacturers in materials, manufacturing, and a range of other medical-device categories.
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From the Editor: Regulations/Standards
From the Editor - FDA Catalog of Tools Helps Accelerate Device Development
FDA has created a “Catalog of Regulatory Science Tools,” in which it provides a comprehensive list of peer-reviewed resources for medical device developers.
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Features: Design
Show Preview: Evolving to MedDev 2021
The "Evolving To MedDev" 2021 digital event will provide automotive and aerospace companies with practical information about how they can enter into the medical device supply chain.
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Features: Regulations/Standards
Testing Strategies for EUA Devices
While many devices have received Emergency Use Authorization (EUA) for short-term use, new testing procedures are needed for the long-term.
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Technology Leaders: Robotics, Automation & Control
Is a Medical Robot Really a Robot?
There are no true "medical robots," says an industry expert. Here's why.
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Features: Wearables
Can a Wearable Stop a Pandemic?
The COVID-19 pandemic has ushered in a new period of growth for wearables.
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Briefs: Wearables
PAs and NPs: How OEMs Can Reach This Critical Audience During the Pandemic
Regulatory changes have allowed these essential healthcare professionals to step in and help out more independently.
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From the Editor: AR/AI
From the Editor: A Look at FDA’s Plan for Artificial Intelligence and Machine Learning in Medical Devices
FDA just released the agency’s first action plan addressing artificial intelligence (AI) and machine learning (ML).
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Features: Medical
New Regulations, New Timelines: How Chemistry Changed in Response to ISO 10993-18:2020
Understand what part 18 of the 1099318 standard means for your product’s overall life cycle.
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Briefs: Regulations/Standards
Medical Device Usability Requirements: Changes to IEC 62366
The updated standard allows the manufacturer to assess and mitigate risks that are associated with correct use and use errors.
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Products: Sensors/Data Acquisition
New Products and Services
Magnetic angle sensors, heat-staking platforms, regulatory software, and more.
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From the Editor: Design
Guest Editorial - Medical Devices: LIFE after the EUA
When the Emergency Use Authorization Act is lifted, the FDA will have a real device review in place, says our guest editor.
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Applications: Medical
Reimagining Knee Replacements with Additive Technology and Artificial Intelligence
To produce an additively manufactured prosthesis, REJOINT starts by 3D modelling the patient’s CT scan.
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Features: IoMT
Are You Ready for the Next UDI Deadline?
As summer 2020 gives way to fall and we continue grappling with unprecedented challenges, healthcare industry efforts persist to ensure that medical supplies are available when and where they are...
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Blog: Regulations/Standards
Medical Devices: LIFE after the EUA
Yes, there will be a day when the U.S. EUA, Emergency Use Authorization Act, will be lifted, the medical device industry goes back to reality, and the FDA regains control of the medical approval process with...
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Features: Medical
EU MDR Economic Operators: Sharing Compliance Duties across the Supply Chain
A number of manufacturers are still in the process of confirming who qualifies as an "Economic Operator."
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Products: Data Acquisition
New Products and Services
Conduits, heat sinks, bioadhesives, and more.
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Blog: Medical
FDA Teams Up with Aetion to Analyze Real-World COVID-19 Data
In an effort to harness diverse streams of data to understand and respond to COVID-19, the U.S. Food and Drug Administration (FDA) has entered into an agreement with Aetionto...
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Features: Regulations/Standards
Q&A: How Do You Protect Your IP?
Philip Nelson, a partner with Knobbe Martens, provides some insights for device companies facing challenges with intellectual property.
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Briefs: Design
Disposable Device Treats Severe Side-Effect of Cancer
The device eliminates oral mucositis, a side effect of chemo- and radiation therapy.
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From the Editor: Test & Measurement
From the Editor - COVID-19 Ushers in New Technologies and a New Paradigm for the Medical Device Industry
FDA has issued multiple emergency use authorizations, loosened regulations for telemedicine, and eased the requirements for production of...
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Blog: Medical
FDA Authorizes First COVID-19 Test for Patient At-Home Sample Collection
The U.S. Food and Drug Administration (FDA) has authorized the first diagnostic test with a home collection option for COVID-19. Specifically, the FDA re-issued the...
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Blog: Regulations/Standards
FDA Creates New Program to Expedite Development of Coronavirus Treatments
The U.S. Food and Drug Administration (FDA) has established new program specifically geared toward expediting the development of potentially safe and effective...
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Features: Medical
Your MDR Strategy: Start with a Gap Analysis
How to make sense of the 566-page Medical Device Regulation (MDR). This article focuses on a strategy to address material information and what should be included in a gap analysis.
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Features: Medical
Class I Manufacturers: 8 Steps to Tackle EU MDR Compliance
Why Class I manufacturers should not place European Medical Device Regulation (EU MDR) compliance at the end of their to-do lists.
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From the Editor: Regulations/Standards
From the Editor - FDA Launches eSTAR: Voluntary Electronic Submission Program for 510(k)s
FDA has kicked off a new voluntary electronic submission program for 510(k)s.
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Top Stories

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INSIDER: Medical

Brain Implant Enables Safer Drug Delivery

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Features: Medical

Built to Adapt: Rethinking Contract Manufacturing for a New Era

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Podcasts: Design

Smarter Pathways for Precision Drug Delivery in Cancer Care

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From the Editor: Medical

From The Editor: Charting the Technologies That Will Shape Medtech in 2026

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Features: Materials

OEM Toll Processing Advances High-Value Products

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Podcasts: Medical

Personalized Medicine and Drug Delivery

Ask the Expert

John Chandler on Achieving Quality Motion Control
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FAULHABER MICROMO brings together the highest quality motion technologies and value-added services, together with global engineering, sourcing, and manufacturing, to deliver top quality micro motion solutions. With 34 years’ experience, John Chandler injects a key engineering perspective into all new projects and enjoys working closely with OEM customers to bring exciting new technologies to market.

Webcasts

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Podcasts: Medical

How Wearables Are Enhancing Smart Drug Delivery

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Podcasts: Design

Developing Sustainable Drug-Delivery Devices

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Podcasts: Design

Smarter Pathways for Precision Drug Delivery in Cancer Care

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On-Demand Webinars: Medical

Understanding Testing and Compliance Requirements for Wireless Medical Devices

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Podcasts: AR/AI

Personalized Medicine and Drug Delivery

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Podcasts: Manufacturing & Prototyping

Material Science Innovations for Medical Devices

Inside Story

Inside Story: Trends in Packaging and Sterilization
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Eurofins Medical Device Testing (MDT) provides a full scope of testing services. In this interview, Eurofins’ experts, Sunny Modi, PhD, Director of Package Testing; and Elizabeth Sydnor, Director of Microbiology; answer common questions on medical device packaging and sterilization.

Videos