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 Trend Now Permanent?

Iraj Daizadeh

No ncmyx, OSF Preprints from Center for Open Science

Abstract: In the United States (US), the Food and Drug Administration (FDA) regulates medical devices (MDs). Though not a fair comparison but for illustrative purposes: a majority of medical products are MDs and not medicines (drug/biologics). Ignoring the minor contribution of drug/biologic-MD combinations, in 2020 alone, there were at least 5000 medical devices (roughly 50% of which were PMAs) registered versus that of 1600 for new or supplemental drug or biologics approvals (of which less than 10% were new). However, as discussed here, since the first recorded FDA MD guideline (February, 1975) until 2015, the number of MD guidelines have been historically stagnate (relative to those of medicines). Even when considering accommodations due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; COVID-19) pandemic and activity in digital health technologies, there still seems to be an upward trend. The question is why and for how long?

Date: 2021-07-04
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DOI: 10.31219/osf.io/ncmyx

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