News & Analysis as of

Pharmaceutical Industry 510(k) RTA

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

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

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

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: 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

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - March 2022

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Arnall Golden Gregory LLP

Don’t Go Changing . . . Unless You Ask FDA

The Food and Drug Administration recently issued a Warning Letter to a medical device manufacturer for making significant changes to its 510(k)-cleared products for uses outside the scope of the 510(k) clearance, among other...more

Alston & Bird

FDA Authorizes Two Oral COVID-19 Drugs – Medical Products Supply Chain Week in Review

Alston & Bird on

In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference...more

Epstein Becker & Green

Unpacking Averages: Popular Ways to Combine Device Functionality

Epstein Becker & Green on

This month, we’re going to look at a visualization that uses network techniques. Visualizing a network is a matter of nodes and edges. If the network were Facebook, the nodes would be people, and the edges would be the...more

Robinson+Cole Health Law Diagnosis

HHS Again Requires FDA Premarket Review for COVID-19 Tests

On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more

Morgan Lewis

UPDATE: Trump Administration’s Midnight Rulemaking to Exempt Certain Class I and II Devices from 510(k) Requirement Rescinded

Morgan Lewis on

In a not-so-unexpected turn of events, the Biden-Harris administration’s Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) rescinded a notice issued by the Trump administration’s HHS...more

Hogan Lovells

HHS withdraws proposal to exempt 84 medical device types from FDA 510(k) process

Hogan Lovells on

On April 16, the U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) published a notice of withdrawal of their January 15 proposal to exempt 84 medical device types ...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

HHS proposal to exempt medical devices from 510(k) process halted

Hogan Lovells on

On January 15, the U.S. Department of Health and Human Services (HHS) published a notice and request for information (RFI) proposing to exempt 91 medical devices – for which the normal regulatory process was temporarily...more

ArentFox Schiff

FDA Issues Enforcement Policy for Telethermographic Systems During COVID-19

ArentFox Schiff on

FDA continues at a relatively fast clip to issue policies intended to help solve a dire problem: the ongoing need to expand the availability of certain medical products in the US that are critical to addressing the COVID-19...more

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