Dive Brief:
- The U.S. Food and Drug Administration cut the time taken to process 510(k) submissions over the first half of 2023.
- The agency took 163 days to reach 510(k) decisions through June, down 24 days compared to last year’s pandemic-affected performance, BTIG analysts wrote in a July research note. The FDA is aiming to make decisions on 510(k) submissions filed in its 2023 financial year in 128 calendar days, on average.
- The analysts shared the figures in a snapshot of FDA activity over the first half of the year. Other findings include a decrease in the number of 510(k) submissions and an increase in the times for processing premarket approval (PMA) applications.
Dive Insight:
The FDA’s performance was a focus of the Medical Device User Fee Amendments 2022 (MDUFA V) negotiations with the medtech industry. As part of the agreement, the FDA committed to hitting an average total time to decision of 128 calendar days for 510(k) submissions it receives in the 2023 financial year and to 112 calendar days by its 2025 financial year.
“For a period of time, during COVID, FDA appeared to be a bit overwhelmed, stretched thin from lower staffing levels, and an influx of new applications for COVID detection. It was having a noticeable impact on MedTech approvals,” the BTIG analysts wrote.
The BTIG midyear database checkup shows the time to decision decreased by about 24 days, which “is a positive,” the analysts wrote. The 186-day average wait in fiscal 2022 was the highest since the analysts began tracking data in 2012.
While timelines for 510(k) submissions are trending down, the backlog of PMA filings that built up during the pandemic is still affecting the figures for premarket approvals. The average days to original PMA approval is 1,013, the BTIG data showed. The figure represents an 84% increase over last year and the longest wait since the analysts began tracking the data.
“Many PMAs are being approved from original submissions in 2019 & 2020 (or even earlier) as the FDA works through a backlog of Original PMA applications,” the analysts wrote.
The average approval time for panel-track supplements was 304 days in the first half of 2023, a 27% decline from from 2022 levels, they added.
