The Food and Drug Administration has cleared more medical devices in the first half of 2026 than it did at the same point last year, but the time it takes to approve them has risen noticeably, according to a recent BTIG analysis of FDA data.
Approval times are climbing.
Related: Benefits Of A Vegan Diet
Device approvals climb while review periods stretch
BTIG analyst Ryan Zimmerman noted that original premarket approvals— the agency’s most rigorous review for high‑risk devices—are up from 13 to 23 through June, a jump of ten approvals compared with the previous year. Yet the average duration to secure such an approval has grown to roughly 599 days, up from about 402 days a year earlier. The report calls the longer timeline “substantially longer,” and points to a handful of outlier cases that have pushed the average upward.
The more common 510(k) clearance pathway, used for lower‑risk devices, also shows a modest slowdown. The average decision time rose by seven or eight days, landing at about 156 days for the first half of 2026. While the increase is smaller than that for premarket approvals, it still adds a noticeable delay for manufacturers seeking market entry.
Overall, the number of 510(k) clearances granted through June reached 1,669, reflecting a 2.5 % year‑over‑year rise if the current pace holds. The FDA also issued 14 de novo classifications during the same period, matching last year’s count, though the time to approval for these grew by just over 8 %.
Related: Why Take Regular Dental Cleanings in Chelsea NYC Seriously
Panel track approvals—supplemental submissions that address major design changes or new indications—climbed nearly 17 % in the first half of the year. However, the average review period for these supplements increased by about 6.5 %.
Zimmerman emphasized that while the higher volume of authorizations is a positive sign, the elongated timelines matter especially for smaller firms. “The timing to approval carries more importance in terms of the implications of capital runway and demand forecasting,” the analyst wrote, highlighting the financial pressure that longer reviews can place on companies with limited resources.
The report arrives amid a staffing push at the FDA’s Center for Devices and Radiological Health. After cutting more than 3,000 positions last year, the agency is now planning to bring in over 2,000 new employees. Remaining staff have been dealing with heavy workloads and turnover, a situation reported by industry sources.
Related: Things to Consider Before Plastic Surgery in Fort Wayne
Data from the BTIG analysis also show that the average days to original premarket approval have been tracked since 2022, with a clear upward trend in the most recent six‑month window. The chart accompanying the report illustrates the jump from roughly 402 days in 2025 to nearly 599 days in 2026, highlighting the shift in review speed.
For the 510(k) pathway, the same chart tracks the average decision time from 2022 onward, revealing a steady but less dramatic rise to the current 156‑day average. The modest increase suggests that while the agency’s overall workload is growing, the impact varies across different approval routes.