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?

Iraj Daizadeh

No 896vw, OSF Preprints from Center for Open Science

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.

Date: 2021-07-06
New Economics Papers: this item is included in nep-isf
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Persistent link: https://EconPapers.repec.org/RePEc:osf:osfxxx:896vw

DOI: 10.31219/osf.io/896vw

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