FDA/​Regulatory

Briefs: FDA/Regulatory

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.

Features: Wearables

Can a Wearable Stop a Pandemic?

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

From the Editor: FDA/Regulatory

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).

Features: FDA/Regulatory

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.

Briefs: FDA/Regulatory

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.

Products: Mechanical & Fluid Systems

New Products and Services: December 2020 Medical Design Briefs

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

From the Editor: FDA/Regulatory

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.

Applications: FDA/Regulatory

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.

Features: FDA/Regulatory

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...

Blog: Medical

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...

Products: Manufacturing & Prototyping

New Products and Services: July 2020 Medical Design Briefs

Conduits, heat sinks, bioadhesives, and more.

Features: Medical

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."

Blog: AR/AI

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 Aetion to...

Briefs: FDA/Regulatory

Disposable Device Treats Severe Side-Effect of Cancer

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.

From the Editor: FDA/Regulatory

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...

Blog: Medical

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...

Blog: FDA/Regulatory

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/Regulatory

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.

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.

Features: FDA/Regulatory

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.

Blog: Medical

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...

Blog: Medical

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...

Blog: Medical

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...

Blog: Medical

FDA Adds More Dates for Town Halls for COVID-19 Test Developers

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...

Blog: FDA/Regulatory

COVID-19: FDA Expands Remote Patient Monitoring

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...

Blog: Medical

COVID-19: FDA Issues Diagnostic Emergency Use Authorization; Expedites Availability of Diagnostics

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