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Since 1976, the Dynamics of US FDA Medical Device Premarket Notifications are Trending Downwards and Premarket Approvals are Trending Upwards, Yet Together There is a Clear Single 20-Year Period: Does this Represent a Structural Transformation for the Industry?

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  • Daizadeh, Iraj

Abstract

There has been concern that the severe acute respiratory syndrome coronavirus 2 (COVID-19) crises may have stifled medical device (MD) development. However, what if a decline was expected based on some non-COVID-19 force? Since 1976, it is shown that the number of FDA MD applications and registrations (comprised of the sum of premarket notifications (PMNs) and approvals (PMAs)) follow a clear 20-year periodic structure (with two well-defined peaks and a trough), while PMNs and PMAs are aperiodic: the former flowing downwards and the latter flowing upwards. It is hypothesized that the MD industry is undergoing a radical structural change and more needs to be done to not only understand these trends but – importantly – to do something to elevate the peaks and the troughs of these metrics of innovation.

Suggested Citation

  • Daizadeh, Iraj, 2021. "Since 1976, the Dynamics of US FDA Medical Device Premarket Notifications are Trending Downwards and Premarket Approvals are Trending Upwards, Yet Together There is a Clear Single 20-Year Period: Does," OSF Preprints 896vw, Center for Open Science.
    • Handle: RePEc:osf:osfxxx:896vw
    DOI: 10.31219/osf.io/896vw
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    References listed on IDEAS

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    1. Daizadeh, Iraj, 2021. "Historically Stagnate, the Number of US FDA Medical Device Guidelines Have Been Growing Quickly Since The Mid-2010s: While Partially Due to COVID-19 and Digital Health Technologies, Is the Upward Tren," OSF Preprints ncmyx, Center for Open Science.
    2. Lucas Bernard & Aleksandr V. Gevorkyan & Thomas I. Palley & Willi Semmler, 2014. "Time scales and mechanisms of economic cycles: a review of theories of long waves," Review of Keynesian Economics, Edward Elgar Publishing, vol. 2(1), pages 87-107, January.
    3. Iraj Daizadeh, 2020. "United States FDA drug approvals are persistent and polycyclic: Insights into economic cycles, innovation dynamics, and national policy," Papers 2012.09627, arXiv.org, revised Feb 2021.
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