News & Analysis as of

Pre-Market Notification

Gardner Law

Navigating the Complex Regulatory Landscape for AI/ML-Enabled Medical Devices

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The rapid advancement of Artificial Intelligence (AI) and Machine Learning (ML) is revolutionizing the healthcare industry. However, as these innovative devices emerge, understanding the complex regulatory landscape becomes...more

King & Spalding

Predetermined Change Control Plans (PCCPs) for Medical Devices: FDA Issues Draft Guidance

King & Spalding on

On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA plans to implement new...more

Harris Beach PLLC

New York Medical and Life Sciences: Year in Review 2023

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From pharmaceuticals to cosmetics, preemption to expert preclusion, New York state and federal courts issued decisions in 2023, which further shaped the landscape in the medical and life sciences legal world. To prepare the...more

Goodwin

FDA Issues Draft Guidance for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

Goodwin on

The US Food and Drug Administration (FDA or the Agency) recently issued its draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more

Goodwin

Avoiding Misbranding: Words Matter When Describing the Regulatory Status of 510(k) Cleared Devices and Registered Device...

Goodwin on

​​​​​​​When it comes to discussing medical devices regulated by the U.S. Food and Drug Administration (FDA), words such as “approved” and “cleared” cannot be used interchangeably as these terms carry a particular meaning....more

Goodwin

Pre-Marketing, Marketing and Discontinuation of Marketing - How to Notify in Luxembourg?

Goodwin on

​​​​​​​The purpose of this Insights post is to consider some practical issues for alternative investment fund managers (“AIFMs”) when undertaking pre-marketing/marketing activities in the European Union following the...more

Proskauer Rose LLP

Preparing for the New FTC Warning-Letter Process in M&A

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With a rash of changes since Chair Lina Khan took command, the Federal Trade Commission is proving the maxim that the only certainty is uncertainty. Its new policy of issuing warning letters to deals that have...more

King & Spalding

FDA Reverses HHS Exemption of Class I and Class II Medical Devices from Section 510(k)

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Premarket Notification Again Required for Patient and Surgeon's Examination Gloves and Dozens of Class II Devices Proposed for Exemption by Former HHS Secretary - On April 16, 2021, the Food and Drug Administration (“FDA”...more

Mintz - Health Care Viewpoints

FDA Reverses 11th Hour HHS Action to Exempt Certain Devices from 510(k) Premarket Requirement

On April 16, 2021, the Food and Drug Administration (FDA) published twin notices in the Federal Register effectively reversing a move by the Trump administration Department of Health and Human Services (HHS) on January 15,...more

Morgan Lewis

Biden Administration Halts Proposal to Exempt Some Class II Devices Currently Subject to Enforcement Discretion from 510(k)...

Morgan Lewis on

In one of the last proposed notices from the US Department of Health and Human Services (HHS) under the Trump administration, HHS removed the 510(k) premarket notification requirement for seven types of gloves and proposed...more

Hogan Lovells

CDRH plan for FY-2021 guidance prioritizes cybersecurity, CDS software, COVID-19 updates

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On October 16, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) announced the list of priority guidance documents that CDRH intends to publish this fiscal year (FY-2021)....more

Dorsey & Whitney LLP

Channel Reinforces that Akorn is the Ceiling not the Floor for MAE Terminations

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2018’s landmark decision Akorn, Inc. v. Fresenius Kabi AG marked the first time that the Chancery Court upheld a buyer’s use of a Material Adverse Effect (MAE) clause to terminate a merger agreement. However, the Court’s...more

Wilson Sonsini Goodrich & Rosati

Court Holds the FDA Cannot Classify an Imaging Agent Medical Device as a Drug

The legal definitions of a drug and a medical device set forth in the Food, Drug, and Cosmetic Act have some important overlapping provisions. Because of the overlapping provisions, theoretically the U.S. Food and Drug...more

Wilson Sonsini Goodrich & Rosati

FDA Finalizes Guidance on Special 510(k) Pathway

The Food and Drug Administration (FDA) recently finalized its guidance on the Special 510(k) Program—an optional pathway to commercial medical devices that have been modified since their previous 510(k) clearance. The Special...more

Orrick, Herrington & Sutcliffe LLP

AIFMD: New Pre-Marketing Rules

On July 12, 2019, the following new EU directive and regulation on cross-border distribution were published in the Official Journal of the European Union...more

Wilson Sonsini Goodrich & Rosati

Digital Health Report - Summer 2019

Avoid Potential Pitfalls When Incorporating Third-Party Software into Wearable Products - The global market for wearable devices continues to expand rapidly. Digital health companies that manufacture and sell their own...more

Stinson LLP

FDA Proposes Pathway for Artificial Intelligence/Machine Learning Software

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Last week, the FDA published a discussion paper outlining a proposed regulatory framework for artificial intelligence/machine learning software as a medical device (AI/ML SaMD)....more

Knobbe Martens

Boston Scientific Buys Venous-Stent Maker VENITI

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Boston Scientific recently announced an agreement to acquire privately-held VENITI, Inc. for $160 million. According to the press release, VENITI submitted a pre-market approval application with the U.S. Food and Drug...more

Arnall Golden Gregory LLP

FDA Issues Guidance on Submitting 510(k)s for Changes to Existing Devices

On October 25, 2017, the Food and Drug Administration (FDA) issued a final guidance document, Deciding When to Submit a 510(k) for a Change to an Existing Device, which describes when a change in a medical device would...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Final Guidance on "Deciding When to Submit a 510(k) for a Change to an Existing Medical Device"

Recently, the U.S. Food and Drug Administration (FDA) issued final guidance on deciding when to submit a new 510(k) premarket notification application for a change to an existing medical device. The guidance is far reaching...more

Knobbe Martens

EU Finalizes Medical Device Regulations

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The European Council has released the final versions of its Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR). According to JDSupra, the Council of the European Union will vote on March 7, 2017...more

Foley & Lardner LLP

Sandoz Asks Supreme Court To Reverse Biosimilar Decision

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On February 16, 2016, Sandoz, Inc. filed a petition for writ of certiorari to the Supreme Court, asking the Court to overturn the Federal Circuit decision that interpreted the “patent dance” provisions of the Biologics Price...more

Foley & Lardner LLP

Biosimilar Pre-Marketing Notice Always Required

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Judge Cohn of the U.S. District Court for the Southern District of Florida has issued another decision interpreting the complicated provisions of the Biologics Price Competition and Innovation Action (BPCIA), ruling that the...more

Parker Poe Adams & Bernstein LLP

NYSE Amends Its Notice and Trading Halt Rule

The New York Stock Exchange has amended Section 202.06 of the NYSE Listed Company Manual to: - expand the pre-market hours during which NYSE-listed companies must provide prior notice of material news, - expand the...more

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