Pablo Morales, MD
What Medical Device Companies Should Do Now that the Federal Government Shutdown is Over and FDA is Back to Full Functionality
Authors: Naghmeh Nouri, Dr. Pablo Morales
What Happened During the Shutdown
Federal government shutdowns strip the FDA of its legal authority to accept user fee-bearing submissions, freezing the review clock on pending applications. The 2025 shutdown ran from October 1 through November 12, lasting 43 days and leaving thousands of device makers in limbo with no clarity on timeline recovery or regulatory next steps. Now that funding has been restored and the FDA is back to full operations, the real challenge is navigating the backlog.
Re-start Submissions, Stay Compliant and Protect Timelines
When the US federal government was shut down, the FDA did not have the legal authority to accept any new user fees, therefore they were not able to accept any new regulatory submissions during this lapse period, and the clock on new submissions is resuming now that funding is secured. Previously suspended activities included:
- New NDAs, ANDAs, BLAs, biosimilars, PMAs, De Novos, 510(k)s, or other fee-bearing applications
- Routine inspections prioritizing only those related to imminent public health threats
- Food and animal programs such as pre-market reviews of novel food and animal feed ingredients and longer-term initiatives
- Compounding and unapproved drugs oversight
- Regulatory science and policy projects
While IDEs, Q-Subs, STeP program, Breakthrough Device Designation or other applications not requiring user fees were not suspended, they were and continue to be potentially slowed. This creates stalled timelines, and a backlog waiting for resources to come back online and a period of transition and uncertainty for both the industry and FDA. As operations resume, there may be a short window where preparation and clarity can give manufacturers a window of advantage. Some of the activities listed here are helpful guidelines that could apply to you, based on where you are with your interface with FDA.
Actions to Take Now
- Confirm of the status of your submission
- Reach out to your Lead Reviewer to re-establish connection
- Prepare the RTA questions and additional information requests
- Check guidance documents and status of recognized consensus standards database
- Check Q-Sub or Pre-Sub meetings and reschedule-if needed
- Expect slower turnaround and budget for it
- If you have not submitted yet, submit soon
- Maintain traceable records of all FDA communications and records
Final Takeaways
The Federal Government Shutdown did not stop all FDA regulatory responsibilities, but it slowed down FDA’s ability to interact with the regulated industry. As FDA operations resume back to full functionality, those with clear documentation, organized responses, and established reviewer relationships will navigate the backlog efficiently, while those without will likely face compounding delays.
Veranex is here to help you regain the momentum on stalled submissions, compliance activities, or market expansion plans. Our experienced team can help navigate the post-shutdown regulatory landscape, offering an expanded set of strategic and operational services to support faster FDA responses and long-term compliance strength, including:
- Submission Restart and Recovery Support
- Regulatory Gap Assessment Post Shutdown
- QMS stabilization and Inspection Readiness
- Regulatory Strategy Review and Re-visit
- Clinical and Real-World Evidence Support
- Labeling, UDIa and Post-Market Surveillance Updates
- Digital Health and AI/ML Regulatory Services
Proactivity paired with Veranex well-thought strategy and specialized expertise will determine how quickly your device application can move forward in these uncertain times.
Let's move fast. Contact Veranex today.
About the authors:
Naghmeh Nouri brings more than 30 years of sophisticated blend of regulatory acumen and business insight across the global medical device landscape including emerging technologies in cardiovascular devices, digital health, AI-driven solutions and various therapeutic medical devices. She partners with executive teams to translate complex regulatory requirements into integrated strategies that align with product development and commercialization goals. With a proven track record in design assurance, verification and validation, risk management, regulatory submissions, CE marking, QMS implementation, and post-market compliance, she also bring particular strength in process validation, outsourced manufacturing oversight, and collaboration with contract manufacturing organizations (CMOs). Her ability to balance strategic vision with operational execution enables organizations to accelerate market access while maintaining the highest standards of quality and regulatory integrity and empower clients to scale with confidence.
Dr. Pablo Morales leads the clinical and medical vision for Veranex’s iCRO business, shaping how we deliver innovative, patient-centered, and compliant solutions for our clients across all phases of development. He brings over 15 years of clinical, regulatory, and scientific leadership experience to his role as Chief Medical Officer at Veranex.
Before joining Veranex, Dr. Morales served in senior leadership roles at the U.S. Food and Drug Administration (FDA), including Chief Medical Officer in the Office of Clinical Evidence and Analysis and Senior Medical Advisor in the Office of Clinical Policy. He provided clinical and regulatory oversight on more than 1,000 medical device submissions and played a key role in implementing the FDA’s Early Feasibility Studies (EFS) program.
A trained vascular and endovascular surgeon, he earned his medical degree from Universidad Pontificia Bolivariana in Colombia, with advanced training at Guy’s and St. Thomas’ Hospital in London and a research fellowship at the Cleveland Clinic.