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FDA De Novo Clearance Medical Devices

Mintz - Health Care Viewpoints

Regulatory Roundup: Important FDA Developments at the End of September 2022

There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary...more

Morgan Lewis

FDA’s Long-Awaited De Novo Classification Rule Is Finally Here

Morgan Lewis on

The US Food and Drug Administration (FDA) has finally issued its final rule establishing requirements for the de novo classification process. The de novo process allows FDA to establish new product classifications for low- to...more

Hogan Lovells

FDA launches list of AI and machine learning-enabled medical devices

Hogan Lovells on

Yesterday, the U.S. Food and Drug Administration (FDA) shared online its list of artificial intelligence and machine learning (AI/ML)-enabled devices that are legally marketed in the U.S. (via 510(k) clearance, De Novo...more

Faegre Drinker Biddle & Reath LLP

FDA’s Final Guidance: “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals,...

The U.S. Food & Drug Administration (FDA) has released a final guidance document entitled, “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications,...more

Hogan Lovells

Uncertainty remains: FDA releases new benefit-risk decision tree for medical device PMAs and De Novos in concert with final...

Hogan Lovells on

On 30 August 2019 the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance document entitled "Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals,...more

Hogan Lovells

CDRH issues final rule on appeals, excluding De Novos from 517A

Hogan Lovells on

On 2 July 2019 the U.S. Food and Drug Administration (FDA) issued a final rule finalizing the category of "517A decisions," previously termed "significant decisions," as well as two accompanying guidance documents related to...more

Mintz - Health Care Viewpoints

Device Modernization Series: FDA’s Proposed De Novo Regulation

In our first Device Modernization series post, we discussed how FDA is proposing to modernize the 510(k) review program. FDA also recently issued a proposed regulation for the De Novo program and linked that proposed...more

Arnall Golden Gregory LLP

It’s De Novo All Over Again: FDA Issues a Proposed Rule to Implement the De Novo Classification Process

In December 2018, the Food and Drug Administration issued a proposed rule that would amend the medical device classification regulation to implement the De Novo classification process. ...more

Mintz - Health Care Viewpoints

FDA 2018 Year in Review (and a Few Thoughts on 2019)

As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs...more

Spilman Thomas & Battle, PLLC

Product Lines - Toxic Torts and Product Liability Insights - Issue 3, 2018

Welcome to the third issue of Product Lines – our quarterly e-newsletter that focuses on toxic torts and products liability issues. For this edition, we are reporting on several important and timely legal issues. As you...more

Latham & Watkins LLP

FDA Announces Planned Changes to the 510(k) Premarket Notification Program

Latham & Watkins LLP on

Agency signals forthcoming changes that could impact manufacturers’ ability to commercialize new medical devices. Background - On November 26, 2018, officials from the Food and Drug Administration (FDA or the Agency)...more

Knobbe Martens

FDA Approves Marketing of Self-Fitting Hearing Aid

Knobbe Martens on

The U.S. Food and Drug Administration recently announced approval for Bose to market their Bose Hearing Aid. According to the press release, the Bose Hearing Aid, which was approved through the FDA’s De Novo premarket review...more

Knobbe Martens

Apple Watch Receives Clearance from FDA as an Over-the-Counter ECG-monitoring Device

Knobbe Martens on

On September 12, 2018, Apple released its new Apple Watch Series 4 with a new ECG app that can take an electrocardiogram (ECG). Apple’s new Apple Watch Series 4 has been granted De Novo classification by the FDA, which allows...more

Knobbe Martens

BrainsWay Deep TMS System Receives FDA Clearance for OCD Treatment

Knobbe Martens on

Israel-based BrainsWay recently announced the de novo FDA clearance of its Deep Transcranial Magnetic Stimulation (TMS) system for treatment of obsessive compulsive disorder (OCD)....more

Jones Day

FDA Permits Marketing of First Autonomous Artificial Intelligence-Based Medical Device

Jones Day on

On April 11, 2018, the U.S. Food and Drug Administration ("FDA") permitted marketing of the first device to use artificial intelligence ("AI") autonomously to detect a medical condition. The device, called IDx-DR, utilizes an...more

Knobbe Martens

FDA Approval for Auris' Robotic Endoscopy Platform

Knobbe Martens on

On March 23, Auris Health, Inc. announced FDA clearance for the Monarch Platform, Auris’ new system for robotic endoscopy. According to Auris Health, the Monarch Platform “integrates the latest advancements in robotics,...more

Knobbe Martens

FDA grants De Novo Market Clearance of Artificial Intelligence Software

Knobbe Martens on

According to a U.S. Food and Drug Administration press release, Viz. AI Contact application was granted De Novo premarket review to Viz.AI’s LVO Stroke Platform. According to PR Newswire, Viz.AI’s LVO Stroke Platform is the...more

Knobbe Martens

First-Ever De Novo Clearance by FDA’s Orthopedic Branch

Knobbe Martens on

According to IlluminOss Medical, Inc.’s recent press release, the company has successfully obtained the first-ever de novo clearance from the FDA’s Orthopedic Branch for its minimally invasive bone stabilizaion system (the...more

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