FDA Approvals: Doing More with Less

The FDA published its mid-year device authorization numbers and the news is bittersweet.

More devices are getting approved in 2026 than at this point last year (good news), but the time it's taking to get there is climbing across every pathway. That's worth knowing if you're an early-stage founder with a limited runway.

The data comes from a mid-year analysis by Ryan Zimmerman, a medical technology analyst at BTIG, a financial services and research firm that tracks FDA activity as a proxy for medtech sector health.

Here's what the analysis of FDA data actually shows:

PMA approvals are up, with 23 approvals through June, a significant increase of 10 from this time last year. The average time from submission to approval has climbed to roughly 599 days, however. That’s up from 402 days in 2025. Removing a handful of outliers, the average drops to around 339 days, which may be a more representative picture of what most applicants are experiencing. That’s more (qualified) good news.

510(k) clearances are trending up about 2.5% year over year, with 1,669 granted through the first half. Average decision time increased to roughly 156 days, up about 5% from last year. 

De Novo classifications came in at 14 devices through June, roughly in line with last year in terms of volume. Average time to approval increased just over 8%.

The headline number and the context together tell a story. FDA is getting more work done, but it’s taking longer to do it. Not surprising given the roughly 3,000 positions that were eliminated in 2025. This could show the agency is becoming more efficient, or it could be a signal of reviewer burnout that will put a drag on second half throughput. The agency plans to hire approximately 2,200 people, but hiring and onboarding takes time and the institutional knowledge lost in a RIF doesn't come back quickly.

The fact that FDA is approving more devices with a reduced workforce means the remaining reviewers are carrying a heavier load. A deficient submission that requires rounds of feedback is now a bigger problem than before. A clean, well-prepared submission that requires minimal dialogue is a competitive advantage.

The 5% increase in days for a 510(k) looks benign but could foreshadow increased times for submissions in the future. Build that buffer in before you need it.

The De Novo data is the most counterintuitive finding in the report. Volume held flat year over year while PMA and 510(k) volumes both grew. If you are building a genuinely novel device with no clear predicate, De Novo may actually be less congested right now relative to available reviewer bandwidth than the 510(k) pathway. That is worth a conversation with your regulatory counsel before you default to a predicate search.

Bottom line, an understaffed FDA doesn't reward optimism about your timeline. It rewards teams who did the work before they submitted.

Rightley McConnell
VP Client Engagement