Laura Dona on Medical Devices

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

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

3/26/2025 / Compliance , Draft Guidance , Enforcement Actions , FDA Warning Letters , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Medical Devices , Public Health , Regulatory Requirements , Risk Management , Warning Letters

Foreign Drug and Medical Device Manufacturers Under a Second Trump Administration: Increased Enforcement Scrutiny?

As discussions intensify about how the second Trump administration will reshape the regulatory landscape for U.S.-based life sciences firms, less attention has been given to the new administration’s regulatory impact abroad....more

2/20/2025 / Department of Justice (DOJ) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Regulatory Reform , Trump Administration

The Boys Are Back in Town: FDA’s Draft Guidance for Compliance With the Phase-Out of LDT Enforcement Discretion

Thin Lizzy famously declared in their 1976 hit, “The Boys are Back in Town.” The same is true almost 50 years later, as the U.S. Food and Drug Administration has announced its plan to phase out its general enforcement...more

7/16/2024 / Clinical Laboratories , Compliance , Diagnostic Tests , Enforcement , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Medical Devices , Pharmaceutical Industry

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

5/3/2024 / 510(k) RTA , Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices , Warning Letters

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

“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

4/2/2024 / Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Misbranding , OEM , Warning Letters

Harmony and Me: FDA Issues Final Rule to Amend Quality System Regulation for Medical Devices

In 1973, Sir Elton John sang, “Harmony and me, we’re pretty good company,” on his classic album, Goodbye Yellow Brick Road. More than 50 years later, the Food and Drug Administration issued a Final Rule to amend the medical...more

2/13/2024 / Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Pharmaceutical Industry , Regulatory Oversight , Regulatory Requirements

Changes in Latitudes, Changes in Attitudes: FDA Issues an Updated Final Guidance Relating to the Breakthrough Devices Program

We remember the late Jimmy Buffett who sang in his 1977 classic, “Changes in latitudes, changes in attitudes; Nothing remains quite the same.” Demonstrating a change in attitude, in September, the Food and Drug Administration...more

10/4/2023 / Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry

[Webinar] FDA Tries to Keep Up: How FDA and Industry Are Trying to Keep Up With Artificial Intelligence - September 13th, 2:00 pm...

FDA has cleared or approved hundreds of products that work with artificial intelligence (“AI”) and acknowledges that the agency and industry need help navigating how FDA-regulated products engage with AI. In response to the...more

9/6/2023 / Artificial Intelligence , Continuing Legal Education , Draft Guidance , FDA Approval , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , Pharmaceutical Industry , Popular , Prescription Drugs , Webinars

AGG Food & Drug Newsletter - August 2023

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

8/18/2023 / Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , NAD , OPDP , Over The Counter Drugs (OTC) , Pharmaceutical Industry , Prescription Drugs , Product Labels , Warning Letters

FDA Tries to Keep Up: FDA Publishes Two New Items Related to Artificial Intelligence

FDA has recently published two much-anticipated items related to artificial intelligence (“AI”), one pertaining to medical devices and the other to drug manufacturing. FDA has cleared or approved hundreds of products that...more

6/16/2023 / Artificial Intelligence , Food and Drug Administration (FDA) , Life Sciences , Machine Learning , Manufacturers , Marketing , Medical Devices , Pharmaceutical Industry , Risk Mitigation

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

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

4/12/2023 / Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Warning Letters

Medical Device Company Hurts Itself and FDA Focuses on the Pain

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

3/29/2023 / Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Warning Letters

Still Comfortably Numb: FDA Issues Revisions to Previous MDDS Guidance

Recently, the Food and Drug Administration published a revision to its final guidance document titled, “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices,” originally issued...more

11/9/2022 / Food and Drug Administration (FDA) , Medical Device Data System , Medical Devices , Pharmaceutical Industry

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

3/15/2022 / 510(k) RTA , FDA Warning Letters , Food & Drug Regulations , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Medical Devices , Pharmaceutical Industry

Roll With the Changes: FDA’s Proposed Amendments to Converge its Quality Management System Requirements With ISO Requirements

In the words of the rock band REO Speedwagon, from the 1978 song “Roll with the Changes,” “It had to happen, felt the tables turnin’.” Earlier this month, the Food and Drug Administration’s Device Good Manufacturing Practice...more

3/15/2022 / Comment Period , Food & Drug Regulations , Food and Drug Administration (FDA) , Healthcare , ISOs , Life Sciences , Medical Devices , Pharmaceutical Industry , Proposed Rules , Regulatory Agenda , Regulatory Reform

[Webinar] FDA Enforcement in the Product Promotion and Advertising World: (A Little Late 2021) Year in Review and Issues to...

Please join AGG Food & Drug attorneys Alan G. Minsk and Laura S. Dona for a complimentary webinar reviewing past FDA letters issued to pharmaceutical and medical device companies for unlawful promotion in 2021 and where FDA...more

2/9/2022 / Advertising , Continuing Legal Education , Enforcement Actions , FDA Warning Letters , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Risk Mitigation , Sales Promotions , Webinars

Laura Dona

Arnall Golden Gregory LLP

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