The EU AI Act has arrived, and the countdown to compliance is on. As of August 2, 2025, penalties, including administrative fines, are in force…
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/ Health, International Law & Trade, Science, Computers, & Technology
In FDA regulatory matters, companies must carefully choose when to challenge the government, and when to comply. In a recent case, Whoop, the Boston-based wearable maker, has chosen to openly challenge the U.S. Food and Drug…
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/ Administrative Law, Health, Science, Computers, & Technology
Gardner Law is excited to announce Navigating What's Next: AI, Compliance, and Regulation in Life Sciences, being held live at the Shashi Hotel in the heart of Silicon Valley on November 6, starting at 9:00 a.m. Pacific Time…
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/ Health, International Law & Trade, Science, Computers, & Technology
A $9.8 million False Claims Act (FCA) settlement between Illumina Inc. and the U.S. Department of Justice (DOJ) is unique among cybersecurity enforcement actions because it didn’t result from a data breach, but, according to DOJ…
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/ Privacy, Health, Science, Computers, & Technology
The New Technology Add-On Payment (NTAP) program remains one of the most powerful and underutilized tools for securing Medicare reimbursement for novel medical technologies. For eligible products, NTAP provides additional…
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/ Administrative Law, Health, Insurance
For many device makers, the biggest commercial hurdle isn’t FDA authorization—it’s the long wait for Medicare to decide on coverage. Historically, the gap between FDA market authorization and a National Coverage Determination…
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/ Administrative Law, Health
Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators…
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/ Administrative Law, Health, Privacy, Science, Computers, & Technology
Anyone who has submitted a medical device for pre-market review knows the financial investment it takes to for FDA to conduct its review. Under the Medical Device User Fee Amendments (MDUFA), certain submissions, including…
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/ Administrative Law, Health
Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a natural part of the product…
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/ Health, Products Liability
In June 2025, the U.S. Food and Drug Administration announced it is evaluating whether to formally define the term ultraprocessed food (UPF)—a move that could influence future labeling regulations, public health guidance, and…
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/ Administrative Law, Consumer Protection, Health
In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s decades-long…
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/ Administrative Law, Health, Science, Computers, & Technology
When products in your shipment violate—or appear to violate—FDA laws and regulations, the FDA may detain your product and issue a Notice of FDA Action with the designation of “Detained.” This notice is considered the Notice of…
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/ Administrative Law, Health, International Law & Trade
The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into device…
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/ Administrative Law, Health, Science, Computers, & Technology
No Safe Harbor: New DOJ Data Export Rule Restricts Deidentified Data Transfer -
This article outlines new requirements from the Department of Justice regarding “bulk sensitive data”, including de-identified, anonymized, and…
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/ Health, International Law & Trade, Privacy
Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions…
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/ Health, Science, Computers, & Technology
