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Articles by Nathan Downing
CMS Grandfathers Certain Breakthrough Devices for NTAP and TPT
The Centers for Medicare & Medicaid Services (CMS) has released its Fiscal Year 2027 Inpatient Prospective Payment System (IPPS) final rule. The rule generally eliminates the alternative New Technology Add-on Payment (NTAP) and outpatient device Transitional Pass-Through payment (TPT) pathways, but CMS added an important exception for certain technologies already in development or approaching commercialization.
Changing FDA: Can the Agency Keep up with Science?
Journal articles presenting new ways to diagnose and treat diseases appear almost daily. They offer promise for patients currently suffering from disease and for those patients who may face these conditions in the future. However, identifying a new way to approach disease is one thing; translating that scientific discovery into an approved medical product is entirely another.
Advertising and Promotion: Time for an Update? | JD Supra
The advertising and promotion process creates many headaches for medtech companies. The start of a new year is a natural time to assess whether your current process is working as intended or creating unnecessary friction. Companies should assess whether the right experts are at the table, whether the process enables efficiency, and whether their process for creating and vetting claims is disciplined and defensible.
FDA Operations During the FY 2026 Government Shutdown | JD Supra
With a federal government shutdown now in effect, FDA has activated its FY 2026 contingency staffing plan. While essential safety activities and user fee–funded reviews will continue, many programs including new submissions and long-term initiatives are paused. Companies should anticipate disruptions in approval timelines, inspections, and policy development. User fee–funded reviews. FDA will continue reviewing pending drug, biologic, and device applications supported by carryover user fees.
FDA Sends 100 Cease-and-Desist Letters: A Warning to Industry | JD Supra
On September 9, 2025, the U.S. Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) dropped a regulatory bombshell: the FDA issued approximately 100 cease-and-desist letters and thousands of letters to industry targeting direct-to-consumer (DTC) drug ads. This sweeping action is being interpreted as the start of a broader shift in FDA’s oversight of promotional content—particularly in digital and broadcast media.
[Hybrid Event] Navigating What’s Next: AI, Compliance, and Regulation in Life Sciences - November 6th, Mountain View, CA | JD Supra
Discounted lodging is available through this link. 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. This is an exclusive, in-person and live-streamed cross-border legal and regulatory forum held in collaboration with international law firm Fieldfisher.
The Value of MDUFA | JD Supra
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 510(k) and PMA submissions, have an associated cost that must be paid before FDA will begin its review. Companies can receive a small business designation to reduce the cost, but the fees can be substantial; the current rate for a full PMA review is $540,783.
FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers | JD Supra
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 design and documentation. While much of the substance tracks prior drafts, the final version crystallizes FDA’s current thinking—especially in light of the requirements imposed by the 2022 Consolidated Appropriations Act.
The Importance of a Clinical Trial Strategy | JD Supra
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. Collecting those data is a time- and money-consuming endeavor that can put a company’s existence at risk. Companies need to take a mindful approach to clinical studies to mitigate risk and have the best chance at success.
FDA’s Latest Untitled Letter: An Enforcement Tell? | JD Supra
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 with, from a warning letter to a simple verbal question asking the basis for a claim, can throw a company into a time and money-consuming effort.
Streamlining Device Changes with Predetermined Change Control Plans (PCCPs) | JD Supra
In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement certain pre-approved modifications without submitting a 510(k) or PMA supplement for each change. By leveraging PCCPs, manufacturers can increase efficiency, accelerate innovation, and allocate resources more strategically.
[Hybrid Event] Due Diligence Decoded: M&A Success in FDA-Regulated Industries - September 20th, Boston, MA | JD Supra
August 20, 2024 September 20th Boston, MA Nathan Downing, Mark Gardner, David Graham, Amanda Johnston, Paul Rothermel Gardner Law + Follow x Following x Following - Unfollow Contact To embed, copy and paste the code into your website or blog: September 20th, 2024 10:00 AM - 1:00 PM ET Loft on Two One Financial Center Boston, MA 02111 Join Gardner Law for a half-day CLE event in person at Loft on Two in Boston, MA or attend virtually.
Medtech Maturity: Assessing Regulatory Readiness | JD Supra
Nathan Downing presented on ways to assess regulatory readiness for medical products at a recent CLE program that Gardner Law hosted in Austin, Texas. If you did not have time to attend or watch live, please read below for some highlights and view the presentation online. It takes a lot to bring a medical product to market in the United States. You need impactful technology and proper resources to develop a product for years without the assurance it will ever see a patient.
[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX | JD Supra
Program Schedule: 9:00 – 9:30am Tips for Assessing Medtech Company Maturity Nate Downing will present an overview on what companies need to consider when formulating a strategy for their FDA-regulated products.
FDA Issues Draft Guidance on Real-World Evidence Use | JD Supra
Overview As the FDA states in its introduction to the draft guidance, its purpose is “to clarify how FDA evaluates real-world data to determine whether they are of sufficient quality for generating real-world evidence that can be used in FDA regulatory decision-making for medical devices.” The draft guidance defines real-world data (RWD) as, “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources,” while it defines real-world...
Artificial Intelligence: Engaging FDA | JD Supra
Nathan Downing presented on artificial intelligence in medical products and strategies for partnering with FDA at a recent CLE program that Gardner Law and Fieldfisher hosted in Huntington Beach, California. If you do not have time to watch the session recording, please read below for some highlights on this topic. FDA continues to see an increase in the amount of medical products incorporating artificial intelligence and machine learning, especially in medical devices.
[Hybrid Event] Mastering Tomorrow's Tech: A Cutting-Edge Approach to Compliance, Privacy, and Regulation - November 9th, Huntington Beach, CA | JD Supra
Join Gardner Law and Fieldfisher live from Huntington Beach, CA for this complimentary CLE event.
Getting What You Paid For: Acquisition Claims Considerations | JD Supra
While the ability to market medical products is bound by the claims that can be lawfully made, it does not mean the claims available at acquisition are all your company will have. Consider developing a plan to create additional claims, but keep in mind the following. Does the desired new claim require a labeling change? Relying on FDA’s June 2018 guidance, Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers, will help answer the first question.
[Hybrid Event] Navigating the M&A Waters of FDA-Regulated Companies - May 18th, Spring Park, MN | JD Supra
VIEW THE AGENDA Join Gardner Law and colleagues live from Lord Fletcher's on Lake Minnetonka, Minnesota for a complimentary CLE event. Hear from a panel of experts on compliance, data breaches, FDA regulations, privacy, and more. Live and virtual attendance options: In person at Lord Fletcher's on Lake Minnetonka, 3746 Sunset Dr, Spring Park, MN Virtually via GoToWebinar (a link will be sent during registration)
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