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

Regulatory changes have allowed these essential healthcare professionals to step in and help out more independently.
Features: Wearables
Can a Wearable Stop a Pandemic?
The COVID-19 pandemic has ushered in a new period of growth for wearables.
White Papers: Medical
What to Consider When Attempting to Meet Fda Requirements on Medical Device Security

There has been an explosion in the number and types of medical devices available on the market. More and more of these devices are connected to the outside...

FDA just released the agency’s first action plan addressing artificial intelligence (AI) and machine learning (ML).
Understand what part 18 of the 1099318 standard means for your product’s overall life cycle.
The updated standard allows the manufacturer to assess and mitigate risks that are associated with correct use and use errors.
Magnetic angle sensors, heat-staking platforms, regulatory software, and more.
White Papers: Medical
Radically Advance Your Health Care Solution with Highly Advanced Simulations

85% of the top 50 health care companies leverage Ansys engineering simulations to drive product and process development. This enables industry-wide in silico...

When the Emergency Use Authorization Act is lifted, the FDA will have a real device review in place, says our guest editor.
To produce an additively manufactured prosthesis, REJOINT starts by 3D modelling the patient’s CT scan.

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...

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...

Products: Manufacturing & Prototyping
New Products and Services: July 2020 Medical Design Briefs
Conduits, heat sinks, bioadhesives, and more.
A number of manufacturers are still in the process of confirming who qualifies as an "Economic Operator."

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 Aetion to...

The device eliminates oral mucositis, a side effect of chemo- and radiation therapy.
Features: FDA/Regulatory
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.

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

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...

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

FDA has kicked off a new voluntary electronic submission program for 510(k)s.
Features: Test & Measurement
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.
Why Class I manufacturers should not place European Medical Device Regulation (EU MDR) compliance at the end of their to-do lists.

The U.S. Food and Drug Administration (FDA) has made policy changes to respond to the urgent need for even faster testing availability. Although laboratories could use the EUA...

The U.S. Food and Drug Administration (FDA) took action May 25, 2020, to make more ventilators available to healthcare personnel in the United States. FDA issued an emergency use...

The U.S. Food and Drug Administration took significant action to help increase the availability of ventilators and accessories, as well as other...

On Wednesday, March 25, 2020 (3–4 p.m. Eastern), the U.S. Food and Drug Administration (FDA) will host a virtual Town Hall for clinical laboratories and commercial...

The Food and Drug Administration (FDA) has issued a new guidance to provide a policy to help expand the availability and capability of noninvasive remote monitoring devices to facilitate...

The U.S. Food and Drug Administration (FDA) has taken two additional significant diagnostic actions during the coronavirus outbreak (COVID-19)...

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Eric Dietsch on the Benefits of Nitinol Wire

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.

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