Are FDA Review Timelines Slipping? What Companies Need to Know

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 of strain are already being felt in CDER, where drug companies report longer response times and reduced transparency. These challenges are not isolated. Similar effects could surface in CDRH related to device submission reviews if the trend continues.

FDA submissions aren’t optional for FDA-regulated companies—they’re a routine and essential part of delivering innovation. But even routine submissions can carry high stakes. Delays can derail launch timelines, disrupt supply chains, and shake investor confidence. In this environment, it’s no surprise that growing uncertainty around the FDA’s review capacity is causing concern across the industry.

To better understand where review timelines stand, we analyzed FDA’s public submission review data across major device pathways. Here’s what we found.

Device Submissions by the Numbers

510(k) Premarket Notifications

FDA cleared over 3,000 510(k)s in the past year. Review times have held steady at around 140 days on average. While this pathway continues functioning at high capacity, communication delays may still occur due to staffing challenges.

Premarket Approvals (PMAs)

PMA submissions remain limited, with just 28 approvals this past year. These complex applications continue to take ~290 days for review. Sponsors should anticipate potential scheduling delays for meetings or advisory panels as FDA resources remain stretched.

De Novo Requests

With 31 approvals in the past year, the De Novo pathway is seeing increased demand, particularly in digital health. Review times hover between 290–310 days, reflecting the resource intensity of these novel applications.

Despite high volumes, review times have not yet slipped—a testament to the resilience of the FDA's core CDRH review teams. Still, there are signs of strain, and medical device companies should be proactive in planning.

What’s Happening at FDA?

Recent reports indicate serious operational headwinds:

• Over 3,500 FDA staff were affected by layoffs earlier this year, including personnel in FOIA, user fee, and administrative roles.
• Some terminations have been reversed, with the FDA acknowledging certain roles as “mission-critical.”
• The agency faces legal pressure from missed FOIA deadlines and delays in critical negotiations tied to the next PDUFA and GDUFA cycles.
• While FDA leadership has stated that device reviewers were not impacted, many insiders report increased workloads and shifting team responsibilities.

What This Means for Companies

While medical device submission review times appear stable for now, companies should prepare for the ripple effects of ongoing disruptions. Here are three key takeaways:

1. Plan for Flexibility
   Build extra time into your regulatory timelines, especially for meetings, RTA responses, and clarification requests. If your submission is time-sensitive (e.g., to avoid a supply disruption), tell the FDA. Be prepared to educate new reviewers unfamiliar with your technology or disease state. For example, including your clinical expert in your Pre-Sub meeting can make a big difference in helping to bridge any gaps.
2. Make Pre-Submissions Count
   With limited reviewer availability, a focused and well-structured Pre-Sub can be your best opportunity to align with the Agency. Don’t waste the opportunity—make sure your questions are clear and that your team is prepared to make the most of the discussion. Also, consider whether an informational pre-submission is valuable for your company. The opportunity to educate FDA while they are in “listening mode” may pay off down the road.
3. Revisit Your Regulatory Strategy
   Now is a good time to refresh your FDA roadmap. Whether you’re contemplating a De Novo, expanding indications, or navigating changes to a cleared device, experienced regulatory counsel can help you anticipate challenges and optimize your path forward.

Final Thoughts

Although most of the recent delays have been reported by drug manufacturers, device manufacturers shouldn’t assume they’re immune. The same underlying factors—resource constraints, shifting internal priorities, and reduced agency responsiveness—could increasingly impact CDRH interactions as well.

For medical device companies, this is the moment to get ahead: tighten internal timelines, focus on submission quality, and proactively engage with the FDA. Whether you’re planning a Pre-Sub, a 510(k), a design change, or a more complex submission, it’s critical to reinforce your regulatory strategy.

How Gardner Law Can Help

Our team supports clients with all types of FDA submissions—from 510(k)s and De Novos to IDEs, PMAs, and submission strategies. If you’re planning a submission, we’re here to help reduce regulatory risk and move your project forward.