Approval volumes for medical technology by the Food and Drug Administration (FDA) are trending down compared to 2023, according to a mid-year analysis, even as the average time to approval rate is decreasing. BTIG analysts recently reviewed FDA approval statistics, highlighting notable trends in 510(k), PMA, De Novo, and Panel Track regulatory approvals, along with the average time to approval.
Starting with 510(k) approvals, there is a noticeable year-over-year (Y/Y) decline of 9.9%. According to FDA data from the first half of 2024 (1H24), 1,507 510(k)s have been approved through June. If this trend continues, with an estimated 1,545 submissions approved in the second half of 2024 (2H24), the total for the year would be around 3,052, marking an 8.8% decrease by year-end. Original PMAs are also seeing a downward trend. Through June, 13 original PMAs were approved, compared to 22 in the same period last year. If 18 PMAs are approved in 2H24, mirroring the run rate of 2H23, the total for the year would be approximately 31, reflecting a 13.9% Y/Y decline.
De Novo Classifications, however, remain steady. Through June, 24 De Novo Classifications have been approved, aligning with last year’s levels. Assuming the second half of the year follows the same trend as 2H23, a total of 48 De Novo Classifications should be approved by the end of the year. Panel Track approvals are also down by about 6.6% Y/Y, with 13 approvals in the first half of the year. If the run rate of 15 approvals in 2H23 is maintained in 2H24, the total number of Panel Track approvals for the year is expected to be around 28.
FDA Medical Technology Approval Wait Times Decrease Despite Lower Approval Volumes
While FDA approval volumes are trending down compared to 2023, wait times for approval have also decreased, meaning companies are facing shorter interim periods while awaiting regulatory decisions. Overall, there has been an average reduction of about 10 days in wait times, with the FDA continuing to shorten the period between submission and clearance.
For 510(k)s, BTIG reported a 5.9% Y/Y decline in average days to submission decision, dropping from about 179.51 days in 2023 to approximately 168.9 days through June 2024. PMAs have seen a significant improvement, with the average days to submission approval decreasing from about 760.8 days in 2023 to around 363.2 days, aligning more closely with historical norms.
In contrast, wait times for De Novo Classification and Panel Track approval decisions have increased in 1H24 compared to 1H23. De Novo approval wait times rose from an average of 415 days in 2023 to 420 days so far this year, a 1.2% increase. Similarly, Panel Track wait times increased from an average of 285.80 days in 2023 to 289.62 days in 2024, a 1.3% rise.
Nuanced Trends in FDA Approvals Impact the Medical Technology Sector
The mixed trends in FDA approval volumes and wait times present a nuanced picture for the medical technology sector. On one hand, the decline in approval volumes may reflect a more rigorous review process or changes in submission rates. On the other hand, the reduction in approval wait times is a positive development, offering greater certainty to companies and investors and reducing cash burn during the interim period when a company awaits a decision.
BTIG analysts Ryan Zimmerman and Iseult McMahon commented on the implications of these trends: “We think that this is a directional positive for the broader medical technology space as it provides both improving certainty to companies (and investors) as well as reduces cash burn during the interim period when a company is awaiting a decision.”
As the year progresses, it will be important to monitor whether these trends continue and how they impact the medical technology landscape. The ongoing improvements in approval wait times could enhance the efficiency and predictability of bringing new medical technologies to market, ultimately benefiting patients and healthcare providers.
Resource: Medical Device and Diagnostic Industry, July 08, 2024
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