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Checking the mid-year numbers, BTIG analysts recently reported on FDAs approval statistics, gleaming interesting trends in 510(k), PMA, De Novo, and Panel Track regulatory nods as well as the average time to approval.

FDA approval rates

Starting with 510(k) approvals, the numbers are trending down year-over-year (Y/Y) by 9.9%. According to FDA data from the first half of 2024 (1H24), 1,507 510(k)s have been approved through June. Assuming the trend continues for the full year — around 1545 submissions approved in 2H24 — equaling around 3052 for 2024, there will be a decrease of about 8.8% by year end.

Through June, 13 original PMAs were approved, down from 22 same time last year. If 18 PMAs are then approved in 2H24 — 2H23s run rate —BTIG analysts said they can estimate around 31 will be approved for the full year, down 13.9% Y/Y.

De Novo Classifications through June amounted to 24, which is on track with last year’s levels. Assuming 2H24 holds true to 2H23’s run rate, 48 De Novo Classifications should be approved by years end, according to the report. Additionally, Panel Track approvals through June are rated at an about 6.6% decline Y/Y as there have only 13 approvals in the first half of the year. If the 2H23 run rate of 15 are approved in 2H24, there will be an expected 28 approvals for the year.

Time to approval

While FDAs medical technology approvals are trending down compared to 2023, so are wait times for approval. This means that companies are having to deal with less of an interim period awaiting regulatory decisions. Overall averaging a decrease of about 10 days of wait time, FDA continues to shave of time between when a company submits its proposal and when FDA announces clearance.

For 510(k)s, BTIG reported an about 5.9% decline Y/Y in average days to submission decision — about 168.9 days through June 2024 compared to about 179.51 days in 2023. PMA’s average days to submission approval improved substantially compared to last year. Coming in about 760.8 days of waiting in 2023 to about 363.2 days, which is reportedly more in line with historical norms.

Both De Novo Classification and Panel Track approval decision wait times, however, did see increases in 1H24 compared to 1H23. De Novo approval wait times raised from an average of 415 days in 2023 to 420 so far this year, a 1.2% growth. Additionally, Panel Track wait times went from an average of 285.80 days in 2023 to 289.62 so far in 2024, a 1.3% increase.

“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,” said BTIG analysts Ryan Zimmerman and Iseult McMahon, in the report.

Article source: MDDI