The duration of the regulatory review and clearance process for medical devices in the U.S. remains at stubbornly high levels, according to a recent assessment.
According to an article posted to the website of MD+DI, FDA 510(k) review times average between 140-175 days for the year to date, a timeframe the article says “remain(s) elevated compared to historical baselines.” Further, between 70-80% of 510(k) submissions exceed the 90-day target review timeframe previously established by the agency.
The extended review times for medical devices have been significantly impacted by staffing cuts implemented by the FDA earlier this year under the federal government’s efficiency initiatives. The article notes that the agency eliminated more than 220 positions in February and made additional staff reductions in April. Staff reductions, as well as other changes at the FDA, have imposed “significant risk to review timelines.”
The article notes that one way to potentially shorten review times would be for medical device manufacturers to take greater advantage of third-party review programs. Currently, only 14% of eligible 510(k) submissions utilize the third-party pathway. Choosing this option would help to shift the review burden, especially for those 510(k) applications that lead to additional information requests during a substantive review.
The MD+DI article detailing its assessment of FDA clearance times in 2025 is available at https://www.mddionline.com/medical-device-regulations/factors-influencing-fda-clearance-time-for-medical-devices-evolution-of-a-critical-regulatory-pathway.