FDA/​Regulatory

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.

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.

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.

Is a Medical Robot Really a Robot?

There are no true "medical robots," says an industry expert. Here's why.

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.

Can a Wearable Stop a Pandemic?

The COVID-19 pandemic has ushered in a new period of growth for wearables.

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).

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.

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.

New Products and Services: December 2020 Medical Design Briefs

Magnetic angle sensors, heat-staking platforms, regulatory software, and more.

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.

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.

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...

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...

New Products and Services: July 2020 Medical Design Briefs

Conduits, heat sinks, bioadhesives, and more.

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."

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...

Disposable Device Treats Severe Side-Effect of Cancer

The device eliminates oral mucositis, a side effect of chemo- and radiation therapy.

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.

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...

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...

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...

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.

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.

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.

FDA Expedites Review of Diagnostic Tests to Combat COVID-19

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...

FDA Issues Emergency Use Authorization for Ventilators

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...

COVID-19: FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators

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