Design & Testing

FDA/​Regulatory

Topics:

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.

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Technology Leaders: Regulations/Standards
Modern evaluation of biocompatibility uses a risk-based approach.
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Features: Regulations/Standards
Bring your project from the process development phase of manufacturing to a fully validated one.
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From the Editor: Regulations/Standards
New best practices for understanding medical device security.
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Supplements: Sensors/Data Acquisition
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.
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Features: Regulations/Standards
A robust, optimized mechanical testing program is essential to successful quality control testing.
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Products: Materials
Linear stepper stages, tubing, Bluetooth modules, and more.
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Briefs: Medical
Deadlines are approaching for compliance.
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Features: Regulations/Standards
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: Robotics, Automation & Control
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: Medical
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: Manufacturing & Prototyping
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
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
There are no true "medical robots," says an industry expert. Here's why.
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Features: Regulations/Standards
The COVID-19 pandemic has ushered in a new period of growth for wearables.
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Briefs: Regulations/Standards
Regulatory changes have allowed these essential healthcare professionals to step in and help out more independently.
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From the Editor: Regulations/Standards
FDA just released the agency’s first action plan addressing artificial intelligence (AI) and machine learning (ML).
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Features: Medical
Understand what part 18 of the 1099318 standard means for your product’s overall life cycle.
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Briefs: Medical
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: Regulations/Standards
Magnetic angle sensors, heat-staking platforms, regulatory software, and more.
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From the Editor: Regulations/Standards
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
To produce an additively manufactured prosthesis, REJOINT starts by 3D modelling the patient’s CT scan.
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Features: Medical

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

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...

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Features: Regulations/Standards
A number of manufacturers are still in the process of confirming who qualifies as an "Economic Operator."
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Products: Electronics & Computers
Conduits, heat sinks, bioadhesives, and more.
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Blog: AR/AI

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
Philip Nelson, a partner with Knobbe Martens, provides some insights for device companies facing challenges with intellectual property.
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Briefs: Manufacturing & Prototyping
The device eliminates oral mucositis, a side effect of chemo- and radiation therapy.
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From the Editor: Wearables

FDA has issued multiple emergency use authorizations, loosened regulations for telemedicine, and eased the requirements for production...

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Ask the Expert

Ralph Bright on the Power of Power Cords
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Understanding power system components and how to connect them correctly is critical to meeting regulatory requirements and designing successful electrical products for worldwide markets. Interpower’s Ralph Bright defines these requirements and explains how to know which cord to select for your application.

Inside Story

Inside Story: Developing a Package Performance Testing Plan
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To find out more about the expertise required to develop a testing plan for package performance testing, MDB recently spoke with Sunny Modi, Director of Package Testing for Eurofins Medical Device Testing in Lancaster, PA.

Videos