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Background: The US Food and Drug Administration (FDA) regulates medicaldevices (MD), which are predicated on a concoction of economic and policyforces (e.g., supply/demand, crises, patents). Assuming that the number of FDAMD (Premarketing Notifications (PMN), Approvals (PMAs), and their sum)Applications behaves similarly to those of other econometrics, this workexplores the hypothesis of the existence (and, if so, the length scale(s)) ofeconomic cycles (periodicities). Methods: Beyond summary statistics, themonthly (May, 1976 to December, 2020) number of observed FDA MD Applicationsare investigated via an assortment of time series techniques (including:Discrete Wavelet Transform, Running Moving Average Filter (RMAF), CompleteEnsemble Empirical Mode with Adaptive Noise decomposition (CEEMDAN), andSeasonal Trend Loess (STL) decomposition) to exhaustively search andcharacterize such periodicities. Results: The data were found to be non-normal,non-stationary (fractional order of integration < 1), non-linear, and stronglypersistent (Hurst > 0.5). Importantly, periodicities exist and follow seasonal,1 year short-term, 5-6 year (Juglar), and a single 24-year medium-term(Kuznets) period (when considering the total number of MD Applications).Economic crises (e.g., COVID-19) do not seem to affect the evolution of theperiodicities. Conclusions: This work concludes that (1) PMA and PMN data maybe viewed as a proxy measure of the MD industry; (2) periodicities exists inthe data with time lengths associated with seasonal/1-year, Juglar and Kuznetsaffects; (4) these metrics do not seem affected by specific crises (such asCOVID-19) (similarly with other econometrics used in periodicity assessments);(5) PMNs and PMAs evolve inversely and suggest a structural industrialtransformation; (6) Total MDs are predicted to continue their decline into themid-2020s prior to recovery.

therapeutic innovation and regulatory science

Seasonal and Secular Periodicities Identified in the Dynamics of US FDA  Medical Devices (1976 2020) Portends Intrinsic Industrial Transformation and  Independence of Certain Crises