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
Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the FDA…
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/ Administrative Law, Health, International Law & Trade
As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and document backlogs to operational restructuring. While core review functions are still running, early signs…
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/ Administrative Law, Health, Science, Computers, & Technology
FDA’s Office of Prescription Drug Promotion (OPDP) is active throughout each year issuing letters challenging promotional labeling they deem noncompliant. Any communication from FDA regarding a promotional claim they disagree…
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/ Administrative Law, Communications & Media Law, Health
The FDA is moving quickly to bring artificial intelligence (AI) into the heart of its regulatory review process. On May 8, 2025, the agency announced the successful completion of its first AI-assisted scientific review—and it’s…
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/ Administrative Law, Health, Science, Computers, & Technology
Many FDA-regulated companies are exploring ways to support diagnostic testing, especially when early diagnosis can impact treatment options. However, funding diagnostic testing tied to a company’s own product raises important…
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/ Administrative Law, Commercial Law & Contracts, Consumer Protection, Health
On March 22, 2025, Gardner Law, PLLC proudly co-hosted a thought-provoking continuing legal education (CLE) event with the Mitchell Hamline School of Law Health Law Institute, titled “AI in Healthcare: Adapting to World-Changing…
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/ Privacy, Health, Science, Computers, & Technology
In the FDA-regulated industry, a compliance program isn’t just a formality—it’s a critical tool for protecting your business, patients, and reputation. Still, too many companies treat compliance policies as static…
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/ Administrative Law, Business Organizations, Health
