Keyword: FDA Compliance/​Regulatory Affairs

FDA/​Regulatory

Stories

Briefs: FDA/Regulatory
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: Data Acquisition
Our 2021 Resource Guide shows you the top manufacturers in materials, manufacturing, and a range of other medical-device categories.
From the Editor: FDA/Regulatory
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: Aerospace
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: FDA/Regulatory
While many devices have received Emergency Use Authorization (EUA) for short-term use, new testing procedures are needed for the long-term.
Technology Leaders: Robotics, Automation & Control
There are no true "medical robots," says an industry expert. Here's why.
Briefs: FDA/Regulatory
Regulatory changes have allowed these essential healthcare professionals to step in and help out more independently.
Features: Wearables
The COVID-19 pandemic has ushered in a new period of growth for wearables.
From the Editor: FDA/Regulatory
FDA just released the agency’s first action plan addressing artificial intelligence (AI) and machine learning (ML).
Features: Medical
Understand what part 18 of the 1099318 standard means for your product’s overall life cycle.
Products: Materials
Magnetic angle sensors, heat-staking platforms, regulatory software, and more.
White Papers: FDA/Regulatory
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...

From the Editor: FDA/Regulatory
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: FDA/Regulatory

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: Medical

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
Conduits, heat sinks, bioadhesives, and more.
Features: Medical
A number of manufacturers are still in the process of confirming who qualifies as an "Economic Operator."
Blog: FDA/Regulatory

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...

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

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

Blog: Design

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: FDA/Regulatory

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

From the Editor: FDA/Regulatory
FDA has kicked off a new voluntary electronic submission program for 510(k)s.
Blog: FDA/Regulatory

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...

Blog: Medical

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...

Blog: FDA/Regulatory

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

Ask the Expert

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.