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.

Latest Briefs & News

Features: Materials
A robust, optimized mechanical testing program is essential to successful quality control testing.
Products: Materials
Linear stepper stages, tubing, Bluetooth modules, and more.
Briefs: Design
Deadlines are approaching for compliance.
Features: Tubing & Extrusion
Rodd Turnquist tells Medical Design Briefs how to select the best pumps for medical devices and accelerating time to market.
Supplements: Packaging & Sterilization
Our 2021 Resource Guide shows you the top manufacturers in materials, manufacturing, and a range of other medical-device categories.
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.
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.
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.
Technology Leaders: Regulations/Standards
There are no true "medical robots," says an industry expert. Here's why.
Features: Wearables
The COVID-19 pandemic has ushered in a new period of growth for wearables.
Briefs: Regulations/Standards
Regulatory changes have allowed these essential healthcare professionals to step in and help out more independently.
From the Editor: Regulations/Standards
FDA just released the agency’s first action plan addressing artificial intelligence (AI) and machine learning (ML).
Features: Regulations/Standards
Understand what part 18 of the 1099318 standard means for your product’s overall life cycle.
Briefs: Regulations/Standards
The updated standard allows the manufacturer to assess and mitigate risks that are associated with correct use and use errors.
Products: Regulations/Standards
Magnetic angle sensors, heat-staking platforms, regulatory software, and more.
From the Editor: Medical
When the Emergency Use Authorization Act is lifted, the FDA will have a real device review in place, says our guest editor.
Applications: Manufacturing & Prototyping
To produce an additively manufactured prosthesis, REJOINT starts by 3D modelling the patient’s CT scan.
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...

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...

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

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

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

Blog: Medical

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...

Blog: Regulations/Standards

The U.S. Food and Drug Administration (FDA) has established new program specifically geared toward expediting the development of potentially safe and effective...

Features: Regulations/Standards
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.
Features: Medical
Why Class I manufacturers should not place European Medical Device Regulation (EU MDR) compliance at the end of their to-do lists.

Ask the Expert

Ralph Bright on the Power of Power Cords

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.

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