News & Analysis as of

510(k) RTA

King & Spalding

Predetermined Change Control Plans (PCCPs) for Medical Devices: FDA Issues Draft Guidance

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On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA plans to implement new...more

Epstein Becker & Green

Unpacking Averages: Intended Use Words Most Common to Devices That Require Clinical Trials

When I was working on my Masters in data science, one of the projects I did was to create an algorithm that would take an intended use statement for a medical device and predict whether FDA would require a clinical trial.  It...more

Arnall Golden Gregory LLP

Love Is Like Oxygen (Unless FDA Thinks You Get Too Much, You Get Too High): FDA Issues a Warning Letter to a Medical Device...

One of the catchiest songs written by the 1970s British glam rock band, Sweet, is “Love Is Like Oxygen,” released in 1978. The chorus includes the lyrics, “Love is like oxygen; you get too much, you get too high.” Apparently,...more

McGuireWoods LLP

Off-Label “Free Speech” Theory Does Not Fly for Convicted Former Medical Device Executives in 1st Circuit

McGuireWoods LLP on

A federal appeals court recently upheld misdemeanor convictions of two former executives of Acclarent Inc, a medical device manufacturer, for commercially distributing an adulterated and misbranded medical device by...more

King & Spalding

FDA Issues Proposed Rule Classifying Certain Wound Dressings and Liquid Wound Washes For the First Time

King & Spalding on

After enactment of the Medical Device Amendments of 1976, which established three regulatory classes for medical devices, the Food and Drug Administration (FDA) has been required to classify all medical devices into Class I,...more

Epstein Becker & Green

Unpacking Averages: The Seasonality of FDA 510(k) Decision-Making and the Impact of Michigan Playing for a National Championship

Frequently, I am asked by clients to predict how long it will take for FDA to review and clear a 510(k).  At a high level, I observe that on average clearance can take 160 days according to the data.  Then, beyond that, I...more

Knobbe Martens

First At-Home Artificial Insemination Kit Receives FDA Clearance

Knobbe Martens on

Mosie Baby, a Texas-based fertility care company, has received clearance from the U.S. Food and Drug Administration for its over-the-counter intravaginal insemination kit.  The kit was developed for those who are unable to...more

Knobbe Martens

FDA Clears ABK Biomedical’s Eye90 Microspheres for Hepatocellular Carcinoma Treatment

Knobbe Martens on

ABK Biomedical successfully secured Breakthrough Device Designation from the FDA on December 5, 2023, for its Eye90 microspheres device, which is indicated for the treatment of unresectable Hepatocellular Carcinoma (HCC). The...more

Hogan Lovells

FDA proposal classifying wound dressings/washes with antimicrobials may require PMAs, new 510(k)s

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) proposed two new rules for classification of certain, previously unclassified wound dressings and liquid wound washes containing antimicrobials, which would categorize...more

Knobbe Martens

FDA Clears Neurovalens’s Modius Sleep for Insomnia Treatment

Knobbe Martens on

Neurovalens successfully secured 510(k) clearance from the FDA on October 27, 2023 for its Modius Sleep device with relation to treatment of insomnia and/or anxiety.   The clearance was supported by data collected from a...more

Hogan Lovells

Post-COVID, FDA still permits changes to non-invasive remote monitoring devices without 510(k)

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has revised its guidance on non-invasive remote monitoring devices used to support at-home patient monitoring, replacing its March 2020 guidance that was limited in effect to the...more

Goodwin

Modernizing the FDA’s 510(k) Program for Medical Devices: Selection of Predicate Devices and Use of Clinical Data in 510(k)...

Goodwin on

On September 6, 2023, the US Food and Drug Administration (FDA) released a trio of draft guidances in its efforts to “strengthen and modernize” the 510(k) Program and provide for more “predictability, consistency, and...more

Knobbe Martens

FDA Releases Draft Guidances on 510(k) Submissions

Knobbe Martens on

On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated recommendations on the 510(k) Program to “keep pace with the increasing complexity of rapidly evolving...more

Hogan Lovells

FDA fills 510(k) guidance gaps with drafts on predicate devices, clinical data, implantables

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has issued three new draft guidances as part of an effort to modernize its 510(k) Program for new products that can be found...more

Epstein Becker & Green

Unpacking Averages: How Accurate Do Class II Medical Devices Need to Be to Obtain 510(k) Clearance?

It’s common for a client to show up at my door and explain that they have performance data on a medical device they have been testing, and for the client to ask me if the performance they found is adequate to obtain FDA...more

Knobbe Martens

FDA on pace for a Record Number of Breakthrough Devices in 2023

Knobbe Martens on

The FDA implemented the breakthrough device program in 2015. The program was designed to expedite review of premarket approval (PMA), 510(k) clearance, and De Novo marketing authorizations. Applicants can seek a breakthrough...more

Epstein Becker & Green

Unpacking Averages: Searching for Bias in Word Embeddings Trained on FDA Regulatory Documents

Epstein Becker & Green on

This post explores how bias can creep into word embeddings like word2vec, and I thought it might make it more fun (for me, at least) if I analyze a model trained on what you, my readers (all three of you), might have written....more

Knobbe Martens

FDA Clears Sonic DL™ for Cardiac MRI Scans

Knobbe Martens on

On June 5, 2023, GE HealthCare announced the FDA 510(k) clearance of Sonic DL™.  GE HealthCare reports that Sonic DL™ is a deep learning-based technology intended to capture cardiac MRI images within a single heartbeat....more

Epstein Becker & Green

Unpacking Averages: FDA FOIA Response Times by Topic of Request

Continuing my three-part series on FOIA requests using a database of over 120,000 requests filed with FDA over 10 years (2013-22), this month’s post focuses on sorting the requests by topic and then using those topics to dive...more

Epstein Becker & Green

Unpacking Averages: Creating an Industry-Specific Index to Track the FDA Regulatory Environment

The regulatory environment at the US Food and Drug Administration (“FDA”) has a tremendous impact on how companies operate, and consequently data on that environment can be quite useful in business planning. In keeping with...more

Knobbe Martens

BIOCORP Receives FDA 510(k) Clearance for Smart Injection Sensor

Knobbe Martens on

French medical device company BIOCORP announced in a press release that it received FDA 510(k) clearance for Mallya, a device that according to the company allows insulin pen injectors to capture and transmit injection data...more

Butler Snow LLP

Can What the Supreme Court Said About Device Clearance in Lohr, a “Derelict on the Waters of the Law,” Finally Be Sunk?[1]

Butler Snow LLP on

Even though they are still quoted, statements in Medtronic v. Lohr, which question whether FDA (Food & Drug Administration) medical device clearance is a judgment about a device’s safety, no longer accurately describe what...more

Epstein Becker & Green

Unpacking Averages: The Difference Between Data and the Truth: Comparing FDA’s UDI Database with FDA’s 510(k) Database

Epstein Becker & Green on

It is certainly easy, when writing code to accomplish some data science task, to start taking the data on face value. In my mind, the data can simply become what they claim to be. But it’s good to step back and remember the...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

Epstein Becker & Green

Unpacking Averages: Finding Medical Device Predicates Without Using FDA’s 510(k) Database

Epstein Becker & Green on

The motivation for this month’s post was my frustration with the techniques for searching the FDA’s 510(k) database. Here I’m not talking about just using the search feature that FDA provides online. Instead, I have...more

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