As medical device firms prepare to bring new products to the U.S. market, many are confronting a growing source of uncertainty: internal resource constraints at the FDA. Specifically, the Center for Devices and Radiological Health (CDRH)—which oversees the 510(k) process—is navigating staffing shortages that are beginning to ripple across the agency’s device review functions.
This is raising a pressing question across the industry:
“Should we move forward with our 510(k) submission now, or wait until the FDA stabilizes?”
Based on what we’re seeing from the front lines—working closely with both regulatory teams and FDA reviewers—our answer is clear: if your submission is strong, submit it. Don’t wait for the perfect window, because it may never come. Instead, use the current environment as a catalyst for tighter strategy, better documentation, and smarter engagement with the FDA.
Read our companion guide for a deeper dive into the 20 components of a 510(k) submission document, specifically. Need expert help navigating the premarket notification process? Learn more about our 510(k) consulting services and contact us today to rapidly access the industry’s top regulatory talent.
Understanding the Pressure Inside the FDA Right Now
The FDA is navigating its most significant internal disruption in years. Recent workforce reductions have affected multiple centers, creating a ripple effect across the agency's review functions.
While the Center for Devices and Radiological Health (CDRH)—which oversees the 510(k) process—has brought back many medical device reviewers (as reported here, here, and here), the broader agency instability is creating new challenges.
The scope extends beyond devices. The Center for Drug Evaluation and Research (CDER) is experiencing what the Wall Street Journal described as a "leadership vacuum," with senior officials departing and others not being replaced. According to a report in Bloomberg Law, staff cuts have left reviewers juggling multiple roles, including some filling in for departed senior leaders while covering their own work—all without the help of support staff who were also affected by the RIFs.
While the agency hasn’t issued any formal changes to review timelines or submission procedures, there's a sense among some device sponsors that we'd characterize as a "general sense of hesitancy and uncertainty" about a few certain fears:
- Longer wait times for pre-submission (Q-sub) feedback and review processes.
- Slower responses to clarification questions mid-review.
- Extended review periods, particularly for submissions involving novel features or complex predicates.
- Leadership gaps affecting decision-making and reviewer guidance.
- Reduced administrative and support infrastructure.
| What we're seeing in practice: As of May 2025, with multiple regulatory projects in progress, we have not experienced noticeably longer review times or delays specifically attributable to staffing issues in the device center. However, the broader agency disruption and reports from the drug side suggest the impact may be building. Some applications across FDA appear to be "idling," and the full effect on remaining reviewers—now operating without both senior leadership and support infrastructure—has yet to be fully realized. |
Despite mixed evidence of actual delays, news about agency instability has created a climate of hesitancy among some sponsors, who fear that proceeding now could result in avoidable setbacks.
From our vantage point, however, firms that press forward with well-prepared submissions are still making meaningful progress. Firms that act decisively now can actually capitalize on the hesitancy of others.
Why Waiting on Your 510(k) Can Backfire
The instability at the FDA makes it tempting to wait for clearer skies. But in today's climate, waiting often introduces more risk than reward.
Here’s why:
What a Proactive 510(k) Strategy Looks Like in 2025
Rather than viewing FDA's constraints as a reason to hesitate, forward-thinking regulatory teams are treating them as a signal to act early—and act with exceptional preparation.
Here's the proactive playbook for navigating the current environment we're running with device teams right now.
1. Build the right regulatory strategy—before you build the fileIdentify the most appropriate predicate device, determine whether the 510(k) pathway is the right fit, and ensure that your classification and testing plan align with current expectations. Take it from us when we say that early missteps in strategy can lead to months of rework or, worse, outright rejection. A clear and aligned regulatory roadmap is the foundation of a successful submission. Read our full explainer for more on that. |
2. Leverage the Q-sub process wiselyEven if feedback takes longer to receive, a well-prepared Q-submission remains one of the best tools for de-risking your 510(k). Use it to confirm your predicate, ask targeted questions, and clarify testing requirements. With leadership gaps affecting reviewer guidance, formal written feedback becomes even more valuable for establishing clear expectations. Given the current environment, make your Q-sub interactions count:
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3. Get your documentation submission-ready nowDon't wait until you've "decided" to submit to get your files in order. Prepare your test data summaries, risk documentation, labeling, and intended use statements now. This gives you time to fix gaps before they become critical—and allows you to submit the moment you're ready. In a stretched system, submission quality becomes a major factor in review efficiency. High-quality files can help minimize back-and-forth and accelerate clearance, while poorly prepared submissions may face even longer delays than usual. |
4. Build in realistic timelinesWhile PDUFA deadlines provide structure for drug reviews, device review timelines are more variable. Given the broader agency pressures, we're recommending building additional buffer time into product launch plans. This is especially important if your strategy depends on hitting specific market windows or if your business timeline hinges on regulatory clearance. |
5. Engage a 510(k) consultant early—not as a last resortWith FDA leadership gaps and stretched reviewer bandwidth, having an experienced 510(k) consultant on your team is more valuable than ever. A seasoned consultant brings up-to-date insights on reviewer expectations, precedent decisions, and common pitfalls—and can help you avoid strategic or technical missteps that cause delays. They also act as a liaison between your team and FDA, helping you frame questions clearly, interpret feedback correctly, and craft submissions that check every box on the first try. In an environment where getting the first cycle right isn't just about speed—it's potentially about survival—the right consultant can make the difference between a stalled review and a streamlined path to market. Talk to us to get paired with our regulatory consultants. |
Final Thoughts and Next Steps: Readiness Is Your Competitive Edge
Yes, the regulatory environment in 2025 is undeniably complex, with FDA navigating significant internal changes that extend well beyond the device center. But complexity shouldn't paralyze your team—it should motivate a more strategic, focused, and exceptionally well-prepared approach to the 510(k) process.
The current landscape presents both challenges and opportunities:
- Challenge: Stretched reviewer bandwidth and leadership gaps may extend timelines.
- Opportunity: Many competitors are hesitating, creating openings for well-prepared submissions.
- Challenge: Organizational change may bring procedural uncertainty.
- Opportunity: Current procedures are known quantities compared to future unknowns.
Firms that are taking action now—shaping strong strategies, engaging early with FDA, and tightening their documentation—are not just better positioned to clear regulatory hurdles. They're better positioned to compete in a market where regulatory success increasingly separates winners from the rest.
The FDA's internal challenges are real, but they're also temporary. Your competitive position in the market, however, can be permanent. Don't let the perfect regulatory moment become the enemy of the perfectly good submission.
If you’re evaluating your path to market and need help navigating today’s challenges, now is the time to start the conversation. The FDA Group offers comprehensive 510(k) consulting services led by experienced regulatory professionals, many of whom are former FDA personnel. Our team provides:
- Regulatory strategy development
- Preparation of 510(k) submissions
- Review and analysis of device and predicate relationships
- FDA interaction management
- Support throughout the review process
- Post-clearance regulatory support
A flawed submission can delay your product launch by months or longer. Our 510(k) consultants provide individualized support to maximize the likelihood of a successful, delay-free submission process. With a 95% success rate (right resource, first time) and 97% client satisfaction rate, we deliver better talent, faster and more cost-effectively than traditional consulting firms. Contact us.
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Guiding 510(k) Preparation and Submission for U.S. Medical Device Market Clearance
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A Few Frequently Asked Questions
Is the FDA experiencing staffing shortages in 2025?
Yes, the FDA has undergone significant workforce reductions (RIFs) and leadership changes across multiple centers. While the Center for Devices and Radiological Health (CDRH) has brought back many medical device reviewers, the broader agency is dealing with leadership gaps, stretched reviewer bandwidth, and reduced administrative support staff.
Which FDA centers are most affected by the staffing issues?
Both the CDER and the CDRH have been impacted. CDER is experiencing what has been described as a "leadership vacuum" with senior officials departing and not being replaced. CDRH has restaffed many reviewer positions but is still operating under broader agency constraints.
Are FDA review timelines actually longer in 2025?
The evidence is mixed. While there are reports of some applications "idling" and concerns about extended timelines, many regulatory consultants report no significant delays in their active 510(k) projects as of May 2025. However, the full impact may still be developing as remaining staff adjust to increased workloads.
Should I delay my 510(k) submission due to FDA staffing issues?
No, delaying your submission is generally not recommended. Companies that wait may face a more congested system later as delayed submissions create backlogs. Well-prepared submissions are still progressing through the system, and acting now can provide a competitive advantage while others hesitate.
How long does a 510(k) review take in 2025?
Standard 510(k) reviews typically take 90 days, though this can vary based on submission complexity and FDA workload. Given current staffing constraints, it's wise to build additional buffer time into your product launch timeline, especially for submissions involving novel features or complex predicates.
Are 510(k) pre-submission meetings (Q-subs) taking longer to schedule?
There may be longer wait times for Q-sub feedback, but these meetings remain one of the most valuable tools for de-risking your 510(k). The formal written feedback becomes even more important in an environment with leadership gaps affecting informal reviewer guidance.
What makes a 510(k) submission "FDA-ready" in the current environment?
A strong 510(k) submission in 2025 should include: proper predicate device selection, comprehensive testing documentation, clear intended use statements, thorough risk analysis, and complete labeling. High-quality submissions minimize back-and-forth with reviewers, which is especially important when reviewer bandwidth is stretched.
When is the best time to submit a 510(k) in 2025?
The best time is when your submission is thoroughly prepared and strategically sound. Don't wait for a "perfect" regulatory window that may never come. Early, well-prepared submissions can capitalize on competitor hesitancy and avoid future backlogs.
Should I use a 510(k) consultant during FDA staffing shortages?
Yes, engaging an experienced 510(k) consultant is more valuable than ever during periods of agency instability. Consultants provide up-to-date insights on reviewer expectations, help navigate FDA interactions, and can prevent strategic missteps that cause delays when reviewer bandwidth is limited.
How do I prepare for potential FDA delays in my business planning?
Build realistic timelines with buffer periods into your product launch plans. Don't hinge critical business decisions solely on hitting specific regulatory deadlines. Consider engaging regulatory counsel early to identify potential red flags before they become costly delays.
Ready to Move Forward? Let’s Talk
If you’re preparing a 510(k) submission in today’s unpredictable regulatory climate, you don’t need to navigate it alone. The FDA Group’s team of seasoned consultants—including former FDA reviewers and industry experts—can help you build a strong, submission-ready strategy that accounts for current review dynamics and sets your team up for success.
- Develop a regulator-aligned 510(k) strategy.
- Tighten your submission documentation before issues arise.
- Accelerate FDA engagement with expert-led Q-subs.
- Mitigate review delays through experienced guidance.
Whether you're still shaping your regulatory plan or ready to finalize your submission, we’re here to help you move forward with confidence. Contact us today to schedule a consultation and take the first step toward a faster, smoother 510(k) clearance.
