Mapping the genealogy of medical device predicates in the United States
Published in PLOS One, 2021
Recommended citation: Pai, DB. “Mapping the genealogy of medical device predicates in the United States,” PLOS ONE, Oct 7, 2021. DOI:10.1371/journal.pone.0258153. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0258153
In the United States, medical devices are regulated and subject to review by the Food and Drug Administration (FDA) before they can be marketed. Low-to-medium risk novel medical devices can be reviewed under the De Novo umbrella before they can proceed to market, and this process can be fairly cumbersome, expensive, and time-consuming. An alternate faster and less-expensive pathway to going to market is the 510(k) pathway. In this approach, if the device can be shown to be substantially equivalent in safety and effectiveness to a pre-existing FDA-approved marketed device (or “predicates”), it can be cleared to market. Due to the possibility of daisy-chaining predicate devices, it can very quickly be difficult to unravel the logic and justification of how a particular medical device’s equivalence was established. From patients’ perspective, this minimizes transparency in the process. From a vendor perspective, it can be difficult to determine the right predicate that applies to their device.
Recommended citation: Pai, DB. “Mapping the genealogy of medical device predicates in the United States,” PLOS ONE, Oct 7, 2021. DOI:10.1371/journal.pone.0258153.