FDA Update

FY 2026 Government Shutdown and how it will AFFECT the FDA Operations Update

As of October 1, 2025, no Fiscal Year (FY) 2026 appropriation or Continuing Resolution (CR) has been enacted for the U.S. Food and Drug Administration (FDA). As a result, the agency has entered a lapse in funding and is operating under its contingency staffing plan. During this period, only select activities that are legally authorized—such as those related to immediate public health threats and functions supported by available carryover user fees—will continue.

Ongoing Activities

Despite limited funding, the FDA remains committed to protecting public health. The following operations will continue during the shutdown:

• User Fee–Funded Reviews: Reviews of existing applications for drugs, biologics, and medical devices will proceed if they are supported by carryover user fee balances. Associated activities, such as regulatory guidance and oversight of clinical trials, will also move forward.
• Essential Safety Functions: The FDA will respond to emergencies including disease outbreaks, manage product recalls, and investigate situations posing urgent public health risks.
• Import Oversight: Screening of imported food and medical products will remain active to prevent the entry of unsafe items into the U.S. market.
• Product Safety Monitoring: Ongoing surveillance of medical devices and other regulated products will continue to identify and mitigate safety concerns.
• Tobacco Regulation: Enforcement and oversight of tobacco-related products will not be interrupted.
• Workforce: Approximately 86% of FDA staff will remain in place—66% funded through user fees and another 19% designated as essential to continue critical functions.

Paused or Delayed Activities

Due to the shutdown, the FDA is unable to accept new user fee payments for FY 2026, and therefore cannot process any submissions that require those fees. Several routine and long-term functions are on hold:

• New Applications: The agency cannot receive or begin reviewing new marketing submissions, including NDAs, ANDAs, BLAs, biosimilars, PMAs, De Novos, and 510(k)s. Timelines for these submissions will not begin until funding resumes.
• Routine Facility Inspections: Standard surveillance inspections are paused, except in situations that present an immediate risk to public health.
• Pre-market Food and Animal Feed Reviews: Evaluations of novel ingredients and related policy work are suspended.
• Oversight of Compounded and Unapproved Drugs: Unless there is an urgent threat to health, regulatory enforcement in this area is on hold.
• Regulatory Science and Policy Development: Research initiatives, staff development, and innovation-focused projects are temporarily suspended until appropriations are reinstated.

Guidance for Industry

• For Active Applications: Continue responding to agency inquiries as quickly as possible, but be prepared for slower communication and potential delays.
• For Upcoming Submissions: Plan ahead and expect timing disruptions. New fee-based submissions will not be accepted during the shutdown.
• For Quality and Compliance Teams: Understand that while routine inspections are limited, the agency retains authority to conduct for-cause inspections and take enforcement action if necessary to address safety concerns.

HOW MDI CONSULTANTS CAN HELP:

FDA shutdowns or delays can create uncertainty, especially for companies in the process of product development, regulatory submissions, or undergoing inspections. However, with proper planning and the right support, these periods can be used strategically to strengthen your regulatory position and internal systems.

With over four decades of experience, mdi Consultants has been helping companies plan ahead, develop sound regulatory strategies, and stay prepared during FDA shutdowns or disruptions. Our team can work closely with yours to:

• Plan and optimize your product design and development process
• Rework or build a new regulatory strategy tailored to your goals
• Assist with regulatory risk assessments and compliance planning
• Prepare your team and documentation to be ready to move forward as soon as FDA operations resume

Additionally, with routine FDA inspections paused, this is an ideal time to assess and enhance your quality management systems. We can help you:

• Set up a quality system compliant with FDA QSR, ISO 13485, ISO 9001, and MDSAP requirements
• Conduct a comprehensive GAP Analysis of your current systems
• Act as a third-party internal auditor to ensure readiness and compliance

More Info

To learn more or discuss how we can support your team, please contact us at info@mdiconsultants.com