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Arnall Golden Gregory LLP

Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications

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The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...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...

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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

Arnall Golden Gregory LLP

Every Little One, Every Little One: FDA Issues a Warning Letter to a Medical Device Reprocessor for Changes to Marketed Products

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“Every little one, every little one,” a song lyric from Bruce Hornsby and the Range’s 1986 single, “Every Little Kiss,” comes to mind when we read a recent Food and Drug Administration Warning Letter issued to a reprocessor...more

Knobbe Martens

Antitrust Lawsuit Brought Against Drug Manufacturer Based on Its Allegedly Improper Listing of Device Patents in the FDA’s Orange...

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As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more

Arnall Golden Gregory LLP

There Must Be Some Misunderstanding: FDA Issues a Warning Letter to a Medical Device Company That Made the Wrong Decision on...

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In 1980, the British rock band, Genesis, released “Misunderstanding.” Forty-three years later, the Food and Drug Administration and a medical device company fell into a misunderstanding about a product’s regulatory...more

Knobbe Martens

Updates in the FDA’s Regulation of Digital Health Technologies

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The FDA issued a warning letter to Abiomed, for failing to seek approval for its Impella Connect System software before putting it on the market. The Impella Connect System software is designed to work with the company’s...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - August 2023

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Arnall Golden Gregory LLP's Food & Drug Newsletter is a roundup 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

Breathe In, Breathe Out: FDA Tells a Medical Device Company It Needs Its OK to Say That First

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In 1994, the rock band Bush sang, “breathe in, breathe out,” in one of its biggest hits, “Machinehead.” In 2023, a medical device company tried to promote its 510(k)-cleared treatment hood/hyperbaric chamber device for...more

Arnall Golden Gregory LLP

Medical Device Company Falls and Can’t Get Up: FDA Issues Warning Letter to Femoral Hip Manufacturer for Unlawful Promotion

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Many of us remember the television commercial where an older woman falls and cries out, “Help! I’ve fallen and I can’t get up.” This image and quote came to our mind when FDA recently issued a Warning Letter to a medical...more

Arnall Golden Gregory LLP

Medical Device Company Hurts Itself and FDA Focuses on the Pain

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Recently, a medical device company received a Warning Letter from FDA for a number of quality-related deficiencies, including issues with Medical Device Reporting (“MDR”), the promptness (or lack thereof) of handling and...more

Goodwin

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

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​​​​​​​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: Device Inspection Citations That Frequently Precede Warning Letters

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Overview - In this month’s post, in the medical device realm I explore what kinds of inspection citations most often precede a warning letter. In this exercise, I do not try to prove causation. I am simply exploring...more

Morgan Lewis

Recent FDA Medical Device Developments in Response to COVID-19

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The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

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On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

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