FDA Authorized More Devices in First Half but Reviews Took Longer, BTIG Says

The Food and Drug Administration authorized more medical devices in the first half of 2026 than in the same period last year, but reviews took longer to complete, according to a BTIG analysis of FDA data described in a research note on Monday, MedTech Dive reported on July 1.

Original premarket approvals, the agency's most stringent review pathway for high-risk devices, are trending ahead of last year, but the timing to approval is "substantially longer," BTIG analyst Ryan Zimmerman wrote, according to the publication. The FDA approved 23 devices via the pathway through June, 10 more than at the same point a year earlier.

Pathway by pathway

The average time to original premarket approval rose to nearly 599 days in the first half, from about 402 days last year, MedTech Dive reported, adding that BTIG attributed the rise to a few outliers. Medical Design & Outsourcing reported that BTIG compared the figure with full-year 2025 and projects about 51 original PMA approvals in 2026 if the trend continues.

For 510(k) clearance, the most-used pathway, the FDA had cleared 1,669 devices through June. MedTech Dive put the average time to decision at roughly 156 days, up seven or eight days, and said clearances were trending up 2.5% year over year at the current pace. Medical Design & Outsourcing reported an average of just over 155 days, up 5% from 148 days in 2025, and a BTIG projection of about 3,239 clearances for the year.

The agency granted 14 De Novo classifications in the first half, the same number as a year earlier, but the average time for those decisions rose to 341 days, up 8.3% from full-year 2025, according to Medical Design & Outsourcing. Panel-track supplements, used for significant design changes or new indications, rose about 17% to 16 approvals, while their average time to approval increased by about 6.5% to 7%, the two publications reported.

Why timing matters

"Overall, we're encouraged by the absolute level of approvals within medical technology tracks but we believe for many reading this, the timing to approval carries more importance in terms of the implications of capital runway and demand forecasting (especially for smaller companies bringing new technologies to market)," Zimmerman said in the report, as quoted by Medical Design & Outsourcing.

The analysis does not establish why reviews slowed. Medical Design & Outsourcing said longer timelines could be a result of job cuts at the FDA, and noted that the device center's annual report for the year ended October 2025 acknowledged "resource challenges" while saying it was on track to meet key review-time targets. MedTech Dive reported that the analysis comes as the FDA looks to hire more than 2,000 new staff after cutting more than 3,000 roles last year, and that remaining device center staff have been grappling with heavy workloads and attrition.